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D007319: Sleep Initiation and Maintenance Disorders

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (5)


Name (Synonyms) Correlation
drug3677 XC221 Wiki 0.50
drug729 Cereset Research Wiki 0.50
drug475 Blood donation from convalescent donor Wiki 0.50
Name (Synonyms) Correlation
drug2047 Mindfulness Based Intervention Wiki 0.35
drug2490 Placebo Wiki 0.02

Correlated MeSH Terms (5)


Name (Synonyms) Correlation
D013315 Stress, Psychological NIH 0.09
D001008 Anxiety Disorders NIH 0.08
D003863 Depression, NIH 0.06
Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.02

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0100785 Insomnia HPO 0.87

Clinical Trials

Navigate: Correlations   HPO

There are 4 clinical trials


1 Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes

Mindfulness training has been gaining popularity in the past decade as a means of improving general well-being. This trend appears in response to the new stressors that have arisen with the increased stress of the 21st century. Studies have shown that the psychological state of metacognitive awareness encapsulated in mindfulness can promote the decreasing of stress as well as the secondary effect of improving sleep quality; both outcome measures of this study. While the body of research evaluating these benefits is growing, there is limited emphasis placed on the individual differences that can affect the overall efficacy of mindfulness training. Our aim in this study is to observe the effects of mindfulness training on perceived stress levels as well as on sleep using subjective measures in a large sample of trainees. To achieve this, participants will be recruited from a pool of people who have signed up for a 4-week foundational mindfulness or 8-week mindfulness based stress reduction course at Brahm Centre. Questionnaires will be administered both before and after these courses to evaluate both stress levels and sleep habits as well as other factors which could contribute to the efficacy of mindfulness training. These inventories will probe the different facets of interpersonal differences that could serve to influence the effectiveness of the mindfulness intervention. In addition, the investigators will also test the effect of conducting the course online during a situation of emergency, like it is the partial lockdown that was implemented in Singapore due to the spread of Covid-19. The proposed study has the potential to provide new insights into the factors that affect the efficacy of mindfulness on stress and sleep, in a situation of non-emergency (until February the 6th 2020) as well as during a period of heightened restrictions (DORSCON Orange, from 7th of February to 6th of April 2020) and a partial lockdown (from 7th of April to 1st of June 2020, or until resume of normal activity). Further, the investigators hope to build an algorithm that can predict the potential effectiveness of mindfulness on a person by person basis. This could serve as a foundation for future recommendations for mindfulness training as well as open the door for future studies that could serve to further customize the mindfulness training framework to accommodate individual differences

NCT04417153
Conditions
  1. Stress, Psychological
  2. Sleep Initiation and Maintenance Disorders
Interventions
  1. Behavioral: Mindfulness Based Intervention
MeSH:Sleep Initiation and Maintenance Disorders Stress, Psychological
HPO:Insomnia

Primary Outcomes

Description: Pittsburgh Sleep Quality Index Score (PSQI) is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep disorder, using a cut-off score of 5. The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score above 5 suggests poor sleep quality. A decrease in PSQI score following intervention would reflect and improvement of sleep quality

Measure: Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index total Score

Time: Up to one month

Description: The PSS measures whether different aspects of life were perceived as stressful by participants on a 5-point scale (where 0 was never and 4 was very often) in the past month. Positively worded questions are reversed scored and all 10 questions ratings are summarised into a total score, which ranges from 0 to 40, with higher scores indicating more perceived stress.

Measure: Change in subjective measures of Stress: Perceived Stress Scale (PSS)

Time: Up to one month

Secondary Outcomes

Description: Measured within the Pittsburgh Sleep Quality Index questionnaire. This is the total perceived time in bed in minutes, calculated as item 3 of the PSQI ("When have you usually gotten up in the morning?") minus item 1 ("When have you usually gone to bed?")

Measure: Change in Subjective Time in Bed (TIB)

Time: Up to one month

Description: Measured within the Pittsburgh Sleep Quality Index questionnaire. Total sleep time reflects the amount of time in minutes participants were effectively sleeping while in bed, without periods of wakefulness, on average over the past month. This will be measured by item 4 of the PSQI questionnaires: "How many hours of actual sleep do you get at night?".

Measure: Change in Subjective Total Sleep Time (TST)

Time: Up to one month

Description: Measured within the Pittsburgh Sleep Quality Index. This is the perceived time, in minutes, that takes participants to fall asleep from the moment they go to bed. This corresponds to item 2 of the PSQI: "How long (in minutes) has it taken you to fall asleep each night?"

Measure: Change in Subjective Sleep Onset Latency (SOL)

Time: Up to one month

Description: Measured within the Pittsburgh Sleep Quality Index questionnaire. In addition to Sleep Onset Latency (Secondary outcome 1), a second subjective measure of sleep quality is extracted from the PSQI: time of perceived wakefulness occurring after defined sleep onset. WASO is calculated by taking into account the total time spent in bed (TST) minus total sleep time (TST) and minus sleep onset latency (SOL), in minutes. High WASO scores reflect low sleep continuity and poor sleep quality.

Measure: Change in Subjective Wake After Sleep Onset (WASO)

Time: Up to one month
2 Insomnia After the COVID-19 Pandemic

The aim of this study is to investigate the levels of insomnia 3 months after (T2) the strict physical distancing government initiated physical distancing protocols related to the COVID-19 pandemic (T1). The study also aims to investigate how predictors measured after and before the COVID-19 pandemic are associated with sleep problems at T2.

NCT04443361
Conditions
  1. Insomnia
  2. Metacognitive Beliefs
  3. Anxiety
  4. Depression
  5. Sleep
MeSH:Sleep Initiation and Maintenance Disorders
HPO:Insomnia

Primary Outcomes

Description: Bergen Insomnia scale is developed as a short measure of insomnia consisting of six items measured on a 8-point Likert-scale (Pallesen et al., 2008)

Measure: Bergen insomnia scale (BIS)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
3 Evaluation of Mental Health Status and Related Factors Among Physical Medicine & Rehabilitation Physicians During the Covid-19 Pandemic

In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Facing this critical situation, health care workers on the front line are at risk of developing psychological distress and other mental health symptoms. Physical medicine and rehabilitation (PM&R) physicians works both in specialty outpateint/inpatient clinic and pandemic outpatient/inpatient clinics during the outbreak. Accordingly, PM&R physicians are expected to be mentally affected by COVID-19 pandemic. In this study we aimed to evaluate mental health status of PM&R physicians and related factors during COVID-19 pandemic. This study is a cross-sectional survey which is conducted on an online platform. Demographic data, working conditions of PM&R physicians and factors that may be related to mental health status is questioned in the survey. The Depression, Anxiety and Stress Scale - 21 (DASS-21) is used to measure the emotional states of depression, anxiety and stress.The Insomnia Severity Index (ISI) is used to assess the severity of both nighttime and daytime components of insomnia.

NCT04500652
Conditions
  1. Anxiety
  2. Depression
  3. Insomnia
  4. Covid19
  5. Coronavirus
MeSH:Coronavirus Infections Sleep Initiation and Maintenance Disorders Depression
HPO:Insomnia

Primary Outcomes

Description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.

Measure: Depression, Anxiety and Stress Scales 21 Score

Time: 5 months

Description: The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.

Measure: Insomnia severity index score

Time: 5 months
4 Cereset Research To Reduce Stress And Anxiety In Healthcare Workers In The Time Of COVID-19

The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress and anxiety in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.

NCT04682197
Conditions
  1. Health Personnel
  2. Stress
  3. Anxiety
  4. Insomnia
  5. Hyperarousal
  6. Corona Virus Infection
  7. Covid19
Interventions
  1. Device: Cereset Research
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Sleep Initiation and Maintenance Disorders Anxiety Disorders
HPO:Insomnia

Primary Outcomes

Description: The Impact of Event Scale- Revised Scale assess intrusion, avoidance, and hyperarousal. The scale includes five new questions in addition to the original Impact of Event Scale created by Mardi Horowitz. Scores range from 0 to 88. Total scores ranging between 24-43 suggest that PTSD is a clinical concern; scores between 33-38 suggest best cutoff for probably PTSD; and scores of 39 and above suggest suppressed immune system functioning. The higher the score, the larger the impact of recent stress. There are three subscales evaluating intrusion avoidance, and hyperarousal.

Measure: Change in Impact of Event Scale-Revised (IES-R)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Secondary Outcomes

Description: The severity of insomnia symptoms is measured using two self-report symptom inventories with each data collection visit. This includes the Insomnia Severity Index (ISI). The ISI is a 7-question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. The higher the score, the more suggestive of insomnia.

Measure: Change in Insomnia Severity Index (ISI)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest increased depression.

Measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.

Measure: Change in Generalized Anxiety Disorder-7 (GAD-7)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience either in civilian life, or related to military service, respectively. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.

Measure: Change in PTSD Checklist for Civilians (PCL-C)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.

Measure: Change in Perceived Stress Scale (PSS)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Quality of Life Scale (QOLS) is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).

Measure: Change in Quality of Life Scale (QOLS)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Interpersonal Support Evaluation List - Shortened Version (ISEL-12) is a 12-item scale that was modified from a 40-item scale used to assess perceptions of social support. Three dimensions are evaluated: appraisal support, belonging support, and tangible support. Each item is scaled from 1 to 4 for "Definitely True" to "Definitely False." Scores are summed and higher scores correlate with more perceived social support.

Measure: Change in Interpersonal Support Evaluation List (ISEL-12)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Multiple Ability Self-Report Questionnaire (MASQ) is a self-report questionnaire commonly used to assess perceived cognitive dysfunction. The MASQ has 38 items and assesses five cognitive domains, including language, visual/perceptual ability, verbal memory, visual memory, and attention.

Measure: Change in Multiple Ability Self-Report Questionnaire (MASQ)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

HPO Nodes


Reports

Data processed on January 01, 2021.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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