Improving Outcomes for Patients With SDB and Insufficient Sleep

NCT ID: NCT04279834

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2025-08-11

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.

Conditions

Sleep Apnea; Insufficient Sleep Syndrome; Sleep; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PAP Treatment

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

Group Type: ACTIVE_COMPARATOR

PAP Treatment

Intervention Type: BEHAVIORAL

Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.

Sleep Education I

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

Group Type: ACTIVE_COMPARATOR

Sleep Education I

Intervention Type: BEHAVIORAL

Motivational enhancement plus participant self-monitoring of sleep.

Interventions

PAP Treatment

Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.

Intervention Type: BEHAVIORAL

Sleep Education I

Motivational enhancement plus participant self-monitoring of sleep.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Over age 18 years
• Diagnosed with mild to moderate sleep disordered breathing (SDB) (Apnea Hypopnea Index of 5-30)

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Safwan Badr

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M. Safwan Badr, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Wayne State University

Detroit, Michigan, United States

Countries

United States

Other Identifiers

R01HL146059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1809001759

Identifier Type: -

Identifier Source: org_study_id