Hypertension Clinical Trial
— RESTOREOfficial title:
Improving Outcomes for Patients With SDB and Insufficient Sleep
The purpose of this study is to look at how sleep disordered breathing (SDB) and not getting enough sleep each night contribute to daytime sleepiness. The investigators also want to determine the treatment that works best for improving daytime sleepiness. In this study, the investigators are comparing 2 programs that may improve symptoms of daytime sleepiness.
Status | Recruiting |
Enrollment | 495 |
Est. completion date | July 31, 2024 |
Est. primary completion date | April 6, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria for enrollment are: - Over age 18 years - Diagnosed with mild to moderate sleep disordered breathing (SDB) (Apnea Hypopnea Index of 5-30) Additional Inclusion Criteria for randomization will be: - ESS score >6 - Total sleep time <7 hours at least 4 nights per week, based on baseline sleep diary. Exclusion Criteria: - Current use of PAP or oral appliance therapy for SDB - Severe respiratory or cardiovascular disease (e.g., ventilatory failure, congestive heart failure) - A recent health event that may affect sleep (e.g. recent surgery or hospitalization) - Current alcohol or substance use disorder (<90 days sobriety) or significant unstable psychiatric comorbidity (e.g., suicidal ideation, psychosis) - Pregnancy or within 6 months post-partum - Commercial drivers and individuals at risk for motor vehicle accidents (MVA) or ESS>18 - Significant comorbid sleep disorders (e.g., severe insomnia, narcolepsy); and - Central sleep apnea (defined as central apnea/hypopnea index >5, and >50% of total AHI). - Use of sedative-hypnotic medications higher than the maximal acceptable therapeutic dose range. |
Country | Name | City | State |
---|---|---|---|
United States | Wayne State University | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wayne State University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epworth Sleepiness Scale (ESS) | ESS is an 8-item questionnaire that assesses general level of daytime sleepiness. Total score ranges from 0 - 24, with higher scores indicating greater sleepiness. | 3-months after randomization | |
Secondary | Reactive hyperemia index | Endothelial function will be measured by peripheral arterial tonometry (PAT) collected by fingertip sensor. Proprietary software is used to calculate a reactive hyperemia index. | 3-months after randomization | |
Secondary | 24-hours Ambulatory Blood Pressure | Blood pressure will be monitored over a 24-hour period. Mean 24-hour blood pressure, mean daytime (6am - 10pm), and mean nocturnal (10pm - 6am) blood pressure will be calculated. | 3-months after randomization | |
Secondary | Fatigue Severity Scale (FSS) | The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a point scale of 1 to 7 from strongly disagree to strongly agree. The minimum possible score is 9 and highest score is 63. A higher score indicates more severe fatigue and impact on the person's activities. | 3-months after randomization | |
Secondary | Psychomotor Vigilance Test (PVT) | PVT is a performance measure of alertness and vigilance. Reaction time to a visual cue, delivered at random intervals varying from 2 to 10 seconds, is measured. The total number of lapses (reaction time >500ms) during the 10 minute test will be used as a measure of objective alertness. | 3-months after randomization |
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