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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Sleep; Sleep Apnea; Insufficient Sleep Syndrome
• Intervention / Treatment: Behavioral: PAP Treatment; Behavioral: Sleep Education I

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.

• Study Type: Interventional
• Enrollment (Estimated): 495
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: M. Safwan Badr, MD, MBA; Phone Number: 3137452038; Email: sbadr@med.wayne.edu
• Study Contact Backup: Name: Jennifer L Martin, PhD; Phone Number: 36080 8188917711; Email: jennifer.martin@va.gov

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University
      • Contact: Nishtha H Pandya; Phone Number: 313-576-3548
      • Contact: Sean Carroll; Phone Number: 313-576-3548

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PAP Treatment; Participants will receive a PAP device and will attend four weekly sessions to receive education about this treatment.	Behavioral: PAP Treatment; Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.
Active Comparator: Sleep Education I; Participants will attend four weekly sessions to receive education about strategies to improve sleep.	Behavioral: Sleep Education I; Motivational enhancement plus participant self-monitoring of sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: M. Safwan Badr, MD, MBA, Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Estimated): April 6, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Endothelial Function; Sleep Apnea; Sleep; Behavioral Intervention; Sleepiness; Alertness
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Apnea Syndromes; Hypertension; Sleep Deprivation
• Other Study ID Numbers: 1809001759; R01HL146059 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No