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

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ClinicalTrials.gov Identifier: NCT04279834
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : July 18, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Safwan Badr, Wayne State University

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.


Condition or disease Intervention/treatment Phase
Sleep Apnea Insufficient Sleep Syndrome Sleep Hypertension Behavioral: PAP Treatment Behavioral: Sleep Education I Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Outcomes for Patients With SDB and Insufficient Sleep
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : April 6, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Psychomotor Vigilance Test (PVT) [ Time Frame: 3-months after randomization ]
    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.

  2. Epworth Sleepiness Scale (ESS) [ Time Frame: 3-months after randomization ]
    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.


Secondary Outcome Measures :
  1. Reactive hyperemia index [ Time Frame: 3-months after randomization ]
    Endothelial function will be measured by peripheral arterial tonometry (PAT) collected by fingertip sensor. Proprietary software is used to calculate a reactive hyperemia index.

  2. 24-hours Ambulatory Blood Pressure [ Time Frame: 3-months after randomization ]
    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. Fatigue Severity Scale (FSS) [ Time Frame: 3-months after randomization ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279834


Contacts
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Contact: M. Safwan Badr, MD, MBA 3137452038 sbadr@med.wayne.edu
Contact: Jennifer L Martin, PhD 8188917711 ext 36080 jennifer.martin@va.gov

Locations
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United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Nishtha H Pandya    313-520-2766      
Contact: Sean Carroll    313-520-2766      
Sponsors and Collaborators
Wayne State University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: M. Safwan Badr, MD, MBA Wayne State University
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Responsible Party: Safwan Badr, Professor of Medicine, Wayne State University
ClinicalTrials.gov Identifier: NCT04279834    
Other Study ID Numbers: 1809001759
R01HL146059 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Safwan Badr, Wayne State University:
Sleepiness
Hypertension
Sleep
Sleep Apnea
Endothelial Function
Alertness
Behavioral Intervention
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Deprivation
Hypertension
Vascular Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders