Covid 19 Research using Clinical Trials (Home Page)
Report for D012893: Sleep Wake Disorders NIH
(Synonyms: Sleep Wa, Sleep Wak, Sleep Wake Disorders)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1979 | Online bibliotherapy programme Wiki | 0.58 |
| drug1980 | Online cognitive behavioral therapy (CBT) Wiki | 0.58 |
| drug1887 | No intervention Wiki | 0.14 |
| drug2311 | Questionnaire Wiki | 0.11 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 3 clinical trials
Clinical Trials
1 Efficacy of an Online Cognitive Behavioral Therapy (CBT) Programme Aiming at Reducing the Stress of Health Workers Involved in the Care of Patients During the Covid-19 Epidemic: a Randomized-controlled Trial
Some preliminary epidemiological research conduct in China in health workers involved in the care of Covid-19 patients has shown high rates of depression (>50%), generalized anxiety disorder (>44%), insomnia (>36%) and stress symptoms (>73%), which negatively impact their well-being as well as their ability to work effectively . These rates were observed during the epidemic peak, but they can also have a long-term mental health effect, both individually, but also in a systemic manner , similar to what has been reported relative to the SARS-CoV-1 . Cognitive behavioral therapy (CBT) is recognized as an effective treatment for stress-reduction, as well as for the prevention of multiple mental health problems in at-risk individuals . Moreover, CBT has been found to be effective in brief online formats , which could make it feasible during the current Covid-19 epidemic. To our knowledge, there are no online CBT programmes targeting stress problems in health workers involved in the care of patients during the current epidemic context. The aim of our study is to evaluate the efficacy of the online CBT programme we have developped to specifically address immediate perceived stress in health workers, as well as the prevention of mental health problems at 3- and 6-months follow-up
NCT04362358 Stress - Prevention of Sleep Disorders, PTSD and Depression Behavioral: Online cognitive behavioral therapy (CBT) Behavioral: Online bibliotherapy programme MeSH:Sleep Wake Disorders
Primary Outcomes
Measure: Significant score reduction at the Perceived Stress Scale Time: T0 inclusionMeasure: Significant score reduction at the Perceived Stress Scale Time: T1 (3-month follow-up)
Measure: Significant score reduction at the Perceived Stress Scale Time: T1 (up to 8 weeks treatment)
Measure: Significant score reduction at the Perceived Stress Scale Time: T2 (6-month follow-up)
2 COVID-19: Prospective Follow-up of Pulmonary Function, Sleep Disorders, Quality of Life and Post-traumatic Stress
The current project is a prospective, multicentric cohort study aiming at a multidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of the consequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to better characterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2 will be included in the study 3 months after their diagnosis: They will be followed at 6 months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3 months and their evolution.
NCT04406324 COVID-19 Other: No intervention MeSH:Sleep Wake Disorders
Primary Outcomes
Description: Pulmonary function 3 months after COVID diagnosis, as measured by diffusion capacity of carbon monoxide (DLCO)
Measure: Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis Time: 3 months after COVID diagnosisSecondary Outcomes
Description: Prevalence of Sleep Disordered Breathing, as measured by polysomnography
Measure: Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis Time: 3 months after COVID diagnosisDescription: Prevalence of sleep disorders, as measured by polysomnography
Measure: Prevalence of sleep disorders 3 months after COVID diagnosis Time: 3 months after COVID diagnosisDescription: Prevalence of ventilatory impairments measured by pulmonary function tests
Measure: Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis Time: 3 months after COVID diagnosisDescription: Prevalence of cardiac impairments measured by cardiac echography
Measure: Prevalence of cardiac impairments 3 months after COVID diagnosis Time: 3 months after COVID diagnosisDescription: Pulmonary function as measured by diffusion capacity of carbon monoxide (DLCO)
Measure: Follow-up of pulmonary diffusion capacity of carbon monoxide Time: From Baseline (3 months after COVID diagnosis) to 5 yearsDescription: Assessment of SDB treatments adherence will be monitored in hours/night
Measure: Follow-up of sleep disorders treatment compliance Time: From Baseline (3 months after COVID diagnosis) to 5 yearsDescription: Assessment of SDB treatments efficacy will be based on the residual AHI index (Apnea Hypopnea/hour) under treatment
Measure: Follow-up of sleep disorders treatments efficacy Time: From Baseline (3 months after COVID diagnosis) to 5 yearsDescription: HLA alleles will be assessed as a component of genetic immune capacity
Measure: HLA alleles aspect of COVID clinical presentation Time: 3 months after COVID diagnosisDescription: KIR loci will be assessed as a different component of genetic immune capacity
Measure: KIR loci aspect of COVID clinical presentation Time: 3 months after COVID diagnosisDescription: metabolome expression in sera
Measure: metabolomic aspect of COVID clinical presentation Time: 3 months after COVID diagnosis3 Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)
COVID-19 is an infectious disease caused by the last coronavirus discovered, called SARS-CoV-2. Symptoms encountered in COVID-19 are: cough, breathing difficulties (dyspnea, chest pain, etc.), pyrexia, anosmia (loss of smell) and/or dysgeusia (loss of taste), but also ENT symptoms (rhinitis type, odynophagia), headaches, asthenia, muscle pain, confusion and diarrhea. Infection with SARS-CoV-2 can also be asymptomatic. COVID-19 can be passed from person to person by respiratory droplets expelled when a person speaks, coughs or sneezes. The currently estimated incubation period ranges from 1 to 14 days, and most often this is around 5 days. According to a literature review, there is strong evidence that COVID-19 has an impact on mental health (anxiety being the most common symptom) whether in the general population, healthcare workers or vulnerable populations. The objective of this project is to assess mental health and sleep disorders within two populations: elderly patients and nursing staff.
NCT04497246 Covid19 Other: Questionnaire MeSH:Sleep Wake Disorders Parasomnias
Primary Outcomes
Description: The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events.Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.
Measure: Impact Event Scale-Revised (IES-R) Time: 15 minutesDescription: Self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD).The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Measure: Generalised Anxiety Disorder-7 (GAD-7) Time: 15 minutesDescription: The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment.
Measure: Patient Health Questionnaire-9 (PHQ-9) Time: 15 minutesDescription: The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measure: Insomnia severity index (ISI) Time: 15 minutesSecondary Outcomes
Description: Age, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).
Measure: Demographic data Time: 1 yearDescription: Hospitalization duration
Measure: Hospitalization duration Time: 1 yearDescription: Hospitalization within the intensive care unit (yes/no) with or without intubation
Measure: ICU stay Time: 1 yearDescription: History of chronic diseases
Measure: Medical history Time: 1 yearDescription: Alcohol consumption : none - stable - increased - diminished
Measure: Alcohol consumption Time: 1 yearDescription: Tobacco consumption : none - stable - increased - diminished
Measure: Tobacco consumption Time: 1 year