Clinical trial NCT04279834: Improving Outcomes for Patients With SDB and Insufficient Sleep
Official title: Improving Outcomes for Patients With SDB and Insufficient Sleep
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Apnea
Insufficient Sleep Syndrome
Sleep
Hypertension
Keywords: Sleepiness
Hypertension
Sleep
Sleep Apnea
Endothelial Function
Alertness
Behavioral Intervention
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-02-21
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments, and mortality risk. A significant proportion of the populace has mild to moderate SDB.

This study is a randomized control trial (RCT) to test the efficacy of a program combining patient monitoring with behavioral techniques across Positive Airway Pressure (PAP) and sleep education. Screening for sleep apnea will be performed based on a phone screening questionnaire and an initial polysomnography (collected from another clinic or collected by research staff). Both objective (actigraphy, Psychomotor Vigilance Test, 24 hour blood pressure monitoring, office blood pressure, and EndoPATTM) and self-report (questionnaire/diary) sleep measures will be collected, as well as other health-related measures. Participants with an Apnea Hypopnea Index (AHI) between 5 and 30, and who meet all inclusion/exclusion criteria will be randomized to one of two educational programs.

Both groups will receive education about SDB and sleep, but only one group will receive PAP devices. This information will be provided to participants as part of the 4-session intervention. Follow-up assessments will be conducted immediately following the intervention and after 3-months.

Main study outcomes (lapses, daytime sleepiness, endothelial function and ambulatory blood pressure) will be assessed at baseline, post treatment and 3 month. Data will be analyzed using "intention to treat" principles, and appropriate statistical methods for clinical trials.

Eligibility criteria: 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.

Primary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 3-months after randomization
Secondary outcomes:
measure: Reactive hyperemia index
timeFrame: 3-months after randomization
measure: 24-hours Ambulatory Blood Pressure
timeFrame: 3-months after randomization
measure: Fatigue Severity Scale (FSS)
timeFrame: 3-months after randomization
measure: Psychomotor Vigilance Test (PVT)
timeFrame: 3-months after randomization
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: M. Safwan Badr, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: