Covid 19 Research using Clinical Trials (Home Page)
Report for D020920: Dyssomnias NIH
(Synonyms: Dyssomnias)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1 | "Calm" is a mindfulness meditation mobile app Wiki | 0.50 |
| drug278 | Calm Meditation App Wiki | 0.50 |
| drug1108 | Questionnaires Wiki | 0.50 |
| drug1149 | Remote Cognitive Behavioral Therapy for Insomnia Wiki | 0.50 |
Correlated MeSH Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020447 | Parasomnias NIH | 1.00 |
| D012893 | Sleep Wake Disorders NIH | 0.89 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 4 clinical trials
Clinical Trials
1 Effects of a Mobile Meditation App on Stress During COVID-19 Pandemic in Outpatient Obstetrics and Gynecology Patients; a Randomized Controlled Trial
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. Many obstetrics and gynecology patients are additionally experiencing increased stress due to the healthcare changes the COVID-19 pandemic has caused including delayed or canceled elective surgeries, visitor restrictions, and telemedicine visits instead of in person clinic visits. Mindfulness meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Mindfulness meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective randomized controlled trial evaluating perceived stress, anxiety, and sleep disturbance in the investigators outpatient OB/Gyn patients at Banner Women's Institute, with the use of a 30 day trial of the mindfulness meditation app, "Calm." All patients would ultimately receive a 30 day free trial of the mobile meditation app, however the intervention group would receive the 30-day free trial immediately and the control group would receive the 30-day free trial after the study period which is 30 days after enrollment. The investigators additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and patient satisfaction with use of the app.
NCT04329533 Perceived Stress Anxiety Sleep Disturbance Other: "Calm" is a mindfulness meditation mobile app MeSH:Dyssomnias Sleep Wake Disorders Parasomnias
Primary Outcomes
Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 0Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items.Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 14Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items.Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 30Secondary Outcomes
Description: Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder.
Measure: Hospital Anxiety and Depression Scale Time: Completed study Day 0 and study Day 30Description: Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance.
Measure: PROMIS Sleep Disturbance Short Form Survey Time: Completed study Day 0 and study Day 30Description: Usage data from mobile app, minutes per day used, days per week used
Measure: Adherence Time: From Day 0 to Day 30Description: Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length and measured with 5-point Likert scale.
Measure: Participant Satisfaction Time: Completed study Day 30Description: Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale.
Measure: Coronavirus Questionnaire Time: Completed study Day 0 and study Day 302 Sleep Quality During COVID-19 Containment in Children 7 to 12 Years Old, Whether or Not Usually Followed in Child Psychiatry
The purpose of this study is to determine whether sleep disturbances in children aged 7 to 12 during COVID-19 containment are more prevalent in children who received routine psychiatric care before containment compared to children who don't have any psychiatric care.
NCT04370210 Sleep Disturbance Behavioral: Questionnaires MeSH:Dyssomnias Sleep Wake Disorders Parasomnias
Primary Outcomes
Description: Sleep quality is assessed in both groups with the Sleep Disturbance Scale for Children (SDSC scale). A score ≥ 45/125 is considered as pathological.
Measure: Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up Time: An average of 1 daySecondary Outcomes
Description: Child depression is measured using Child Depression Inventory Scale (CDI scale). For each item the score is graded by severity from 0 (normal behavior) to 2 (severe).
Measure: Assessment of child depression in both groups Time: An average of 1 dayDescription: Child anxiety is measured using Revised Children's Manifest Anxiety Scale (RCMAS). For each item, child answer by Yes or No. The total score is interpreted using the correspondence tables in function of sex and age
Measure: Assessment of child anxiety in both groups Time: An average of 1 dayDescription: Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). The score obtained is interpreted in function of socio-demographic factors (age, sex, lifestyle, couple status, profession and socio-professional category, education)
Measure: Assessment of the influence of socio-demographic factors on sleep in both groups Time: An average of 1 dayDescription: Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). For their parents, sleep quality and anxiety level are measured with a numerical scale between 0 and 10. For sleep quality, 0 correspond to a very poor quality and 10 to a very good quality. For anxiety level, 0 correspond to no anxiety and 10 to a severe anxiety. The score obtained for child is interpreted in function of their parents score.
Measure: Measure of the correlation between child sleep quality and parents sleep quality (anxiety level) in both groups Time: An average of 1 dayDescription: Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Measure: Assessment of sleep disturbance based on psychiatry diagnoses in the group of children usually followed in child psychiatry Time: An average of 1 dayDescription: Child anxiety is measured using Revised Children's Manifest Anxiety Scale (RCMAS). For each item, child answer by Yes or No. The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Measure: Assessment of child anxiety based on psychiatry diagnoses in the group of children usually followed in child psychiatry Time: An average of 1 dayDescription: Child depression is measured using Child Depression Inventory Scale (CDI scale). For each item the score is graded by severity from 0 (normal behavior) to 2 (severe). The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Measure: Assessment of child depression based on psychiatry diagnoses in the group of children usually followed in child psychiatry Time: An average of 1 day3 Effects of a Mobile App on Health and Well-being During COVID-19 Pandemic in House Staff at Banner University Medical Center Phoenix
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.
NCT04374786 Perceived Stress Anxiety Sleep Disturbance Burnout PTSD Device: Calm Meditation App MeSH:Dyssomnias Sleep Wake Disorders Parasomnias
Primary Outcomes
Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 0Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 14Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 30Secondary Outcomes
Description: Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder.
Measure: Hospital Anxiety and Depression Scale Time: Completed study Day 0, 14, and study Day 30Description: Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance.
Measure: PROMIS Sleep Disturbance Short Form Survey Time: Completed study Day 0, 14, and study Day 30Description: The Impact of Event Scale-6 is a validated post traumatic event survey, 6 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The score ranges from a minimum of 6 to a maximum of 30 with higher scores indicating higher traumatic stress.
Measure: Impact of Event Scale-6 Time: Completed study Day 0, 14, and study Day 30Description: The Maslach Burnout Inventory is a validated burnout survey, 22 questions in length with 3 sub scales including emotional exhaustion, depersonalization, and personal accomplishment. Each question is rated on a 7 point Likert scale ranging from 0 (never) to 6 (every day). The score for each sub scales range from minimum 0 to maximum 18. High scores of emotional exhaustion and depersonalization sub scales and a lower score of personal accomplishment indicates a higher level of burnout.
Measure: Maslach Burnout Inventory Time: Completed study Day 0, 14, and study Day 30Description: Usage data from mobile app, minutes per day used
Measure: Adherence Time: From Day 0 to Day 30Description: Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale. 1= very low, 2=low, 3=moderate, 4=high, 5= very high.
Measure: Coronavirus Questionnaire Time: Completed study Day 0 and study Day 30Description: Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length.
Measure: Participant Satisfaction Time: Completed study Day 304 Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep, Suicidality, and Neuropsychiatric Symptoms
The purpose of this study is to investigate whether an empirically validated treatment for insomnia (CBT-I) administered early in the course of sleep disturbance can prevent insomnia disorder or lessen negative mental health outcomes in the wake of the COVID-19 crisis in adults.
NCT04409743 Sleep Disturbance Insomnia Behavioral: Remote Cognitive Behavioral Therapy for Insomnia MeSH:Dyssomnias Sleep Wake Disorders Parasomnias
Primary Outcomes
Description: Whether the participant has an insomnia clinical diagnosis will be measured by the DUKE. The DUKE is a structured interview which screens for sleep disorders in accordance with criteria of both the DSM-IV and the international classification of sleep disorders (ICSD-2). The DUKE is composed of 4 modules that assess sleep disorder symptoms associated with complaints of insomnia, sleep disorders associated with complaints of hypersomnia, circadian rhythm sleep disorders, and sleep disorders associated with parasomnias.
Measure: Change in Insomnia Clinical Diagnosis Time: Assessed at week 0 and week 15Description: This measure is of the Beck Depression Inventory-II total score after excluding one sleep item. The average item score for the remaining 20 items will be multiplied by 21 (the original number of items), to create a modified depression scale that maintains the original range (ranges: 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe). The BDI-II is a 21-item self-report scale with high validity and reliability that assesses the severity of depression symptoms. The depression items consist of: sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. Items are scored from 0 to 3, and higher scores indicate greater levels of severity.
Measure: Change in Beck Depression Inventory-II (BDI) Scale Score Time: Assessed at week 0 and week 15Description: Clinical anxiety symptoms will be measured by the BAI. The BAI is a 21-item self-report scale that assesses the severity of anxiety symptoms. Items are scored from 0 to 3 (0 = not at all, 3 = severe). Higher scores indicate greater levels of severity, and the ranges for anxiety levels are: 0-9 normal to minimal, 10-18 mild to moderate, 19-29 moderate to severe, and 30-63 severe. The BAI consists of two factors: somatic and cognitive.
Measure: Change in Beck Anxiety Inventory (BAI) Scale Score Time: Assessed at week 0 and week 15Description: The SF-36 is a 36-item self-administered survey to assess comprehensive quality-of-life measures. It consists of eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, and mental health. This survey is widely used and has been proven to be a reliable indicator of quality-of-life measures. The global score range is 0-100, with higher scores indicating better health conditions.
Measure: Change in Quality of Life (SF-36) Scale Score Time: Assessed at week 0 and week 15Description: Suicidality ideation and behaviors will be measured by the S-STS. The S-STS is a 16-item 0 to 4 scale (0 = no problem, 4 = very severe problem) that assesses the risk of suicidality. For this outcome measure, 15 items (excluding #13) are summed for an overall score range of 0 to 45 (higher scores indicate more severe problems).
Measure: Change in Sheehan Suicidality Tracking Scale (S-STS) Score Time: Assessed at week 0 and week 15Description: The FIRST is 9 item self-report that assess sleep reactivity with individual items scored on a 1 - 4 scale (1 = Not Likely, 4 = Very Likely). This self-report tools measures the risk of participants experiencing situational insomnia due to common stressful conditions. The FIRST has good reliability and validity and has demonstrated high internal consistency across multiple demographics in both males and females, in young and middle-aged adults, and in clinical and population-based samples. Individual items are summed for a total score range of 9 to 36, with higher scores corresponding to more difficulty sleeping
Measure: Change in Ford Insomnia Response to Stress Test (FIRST) Scale Score Time: Assessed at week 0 and week 15Description: Loneliness risk factors will be assessed with the UCLA Loneliness Scale that measures a participant's subjective feelings of loneliness and social isolation. The UCLA Loneliness Scale has 20 items, each on a 1 to 4 scale (1 = Never, 4 = Often), summed for an overall range of 20 to 80 with higher scores indicating greater degrees of loneliness.
Measure: Change in UCLA Loneliness Scale Score Time: Assessed at week 0 and week 15Description: The Social Network Index is a 12-item questionnaire that assess participation in different types of social relationships. The 12 types of relationships (e.g. friend, children, spouse, religious group member) are scored by the number network members they communicate with at least every 2 weeks.
Measure: Change in Social Network Index (SNI) Scale Score Time: Assessed at week 0 and week 15Description: The Perceived Stress Scale is a widely used self-reported questionnaire that assesses how stressful participants believe their live is. Items are generalized and measure the degree participants judge their lives to be uncontrollable and unpredictable over the course of the previous month.
Measure: Change in Perceived Stress Scale Score Time: Assessed at week 0 and week 15Description: Self-report questions regarding screen time will be included in the Coronavirus Health Impact Survey. Questions measure the amount of time spent per day, over the course of the two most recent weeks, using an electronic device.
Measure: Change in Screen Time- Self Report Time: Assessed at week 0 and week 15Description: The International Physical Activity Questionnaire assess an individual's physical activity across 5 life domains over the last 7 days. The activity domains consist of physical activity related to work, transportation, housework and caring for family, and recreation and sports as well as the amount of time spent sitting. The IPAQ has high reliability and validity and has been widely used to measure comparable estimates of physical activity in large populations.
Measure: Change in International Physical Activity Questionnaire (IPAQ) Scale Score Time: Assessed at week 0 and week 15Secondary Outcomes
Description: Sleep Onset Latency (SOL) is the time (minutes) from "lights out" to actually falling asleep (sleep onset) based on sleep logs.
Measure: Change in Sleep Onset Latency (SOL) as a Measure of Sleep Continuity Time: Assessed at week 0 and week 15Description: Number of Arousals is determined by number of times of awakening as seen on the actigraph data.
Measure: Change in Number of Arousals as a Measure of Sleep Continuity Time: Assessed at week 0 and week 15Description: Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset).
Measure: Change in Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity Time: Assessed at week 0 and week 15Description: Total Sleep Time (TST) is the total time spent asleep, from the start of sleep onset to sleep offset subtracting any periods of wakefulness.
Measure: Change in Total Sleep Time (TST) as a Measure of Sleep Continuity Time: Assessed at week 0 and week 15Description: Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.
Measure: Change in Sleep Efficiency (SE) as a Measure of Sleep Continuity Time: Assessed at week 0 and week 15Description: Subjective ratings of sleep disturbance and insomnia severity will be assessed with the Insomnia Severity Index. The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia type, severity, and impact on functioning. The items consist of severity of sleep onset, sleep maintenance, early morning awakenings, sleep dissatisfaction, interference with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Items are scored from 0 to 4 (0 = no problem, 4 = very severe problem). Score ranges of insomnia are: 0-7 absent, 8-14 sub-threshold, 15-21 moderate, and 22-28 severe. The ISI has good validity and reliability.
Measure: Change in Insomnia Severity Index (ISI) Scale Score Time: Assessed at week 0 and week 15Description: The PHQ-9 is a self-administered 9-item 0 to 3 scale (0 = not at all, 3 = nearly every day) questionnaire that assess each of the 9 DSM-IV depression criteria. The total score ranges from 1 - 27 which measures the severity of the reported depression with consideration for both Major Depressive Disorder and other depressive disorders based on the number of items that were rated a 2 to 3.
Measure: Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms Time: Assessed at week 0 and week 15Description: The GAD-7 is a widely used diagnostic self- report scale that screens, diagnoses, and assess severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score Time: Assessed at week 0 and week 15