Improving Outcomes for Patients With SDB and Insufficient Sleep

NCT04279834 | Completed DMC

• 2 other identifiers: 1809001759R01HL146059
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Insufficient Sleep Syndrome; Sleep; Hypertension

Keywords

Sleepiness; Hypertension; Sleep; Sleep Apnea; Endothelial Function; Alertness; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Reactive hyperemia index

  3-months after randomization

• 24-hours Ambulatory Blood Pressure

  3-months after randomization

• Fatigue Severity Scale (FSS)

  3-months after randomization

• Psychomotor Vigilance Test (PVT)

  3-months after randomization

Study Arms (2)

PAP Treatment

ACTIVE COMPARATOR

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

Behavioral: PAP Treatment

Sleep Education I

ACTIVE COMPARATOR

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

Behavioral: Sleep Education I

Interventions

PAP Treatment BEHAVIORAL

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

PAP Treatment

Sleep Education I BEHAVIORAL

Motivational enhancement plus participant self-monitoring of sleep.

Sleep Education I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Deprivation; Hypertension; Sleepiness

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• M. Safwan Badr, MD, MBA

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: October 16, 2020
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)