Improving Outcomes for Patients With SDB and Insufficient Sleep (RESTORE)

Wayne State University

Status: Completed

Conditions: Hypertension; Sleep Apnea; Insufficient Sleep Syndrome; Sleep

Treatments: Behavioral: PAP Treatment; Behavioral: Sleep Education I

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04279834

R01HL146059 (U.S. NIH Grant/Contract)

1809001759

Details and patient eligibility

About

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.

Full 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.

Enrollment: 558 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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558 participants in 2 patient groups

PAP Treatment

Active Comparator group

Description:

Participants will receive a PAP device and will attend four weekly sessions to receive education about this treatment.

Treatment:

Behavioral: PAP Treatment

Sleep Education I

Active Comparator group

Description:

Participants will attend four weekly sessions to receive education about strategies to improve sleep.

Treatment:

Behavioral: Sleep Education I