Sleep ApneaRESTORENCT04279834
Improving Outcomes for Patients With SDB and Insufficient Sleep
A study testing PAP Treatment and Sleep Education I in people with Sleep Apnea and Insufficient Sleep Syndrome, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Insufficient Sleep Syndrome, Sleep
- What is being tested?
- PAP Treatment and Sleep Education I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 11 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- PAP Treatment, Sleep Education I
- Keywords
- Sleepiness, Hypertension, Sleep, Sleep Apnea, Endothelial Function, Alertness, Behavioral Intervention
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Deprivation, Hypertension, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAP TreatmentBehavioural
Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.
Sleep Education IBehavioural
Motivational enhancement plus participant self-monitoring of sleep.
| Study group | Role | What they receive |
|---|---|---|
| PAP Treatment | Active comparator | Participants will receive a PAP device and will attend four weekly sessions to receive education about this treatment. Receives: Behavioral: PAP Treatment |
| Sleep Education I | Active comparator | Participants will attend four weekly sessions to receive education about strategies to improve sleep. Receives: Behavioral: Sleep Education I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-months after randomization
Secondary outcomes (4)
Reactive Hyperemia Index
Reactive Hyperemia Index (RHI) is a measure of endothelial function assessed using peripheral arterial tonometry (PAT) with the EndoPAT device (Itamar Medical Ltd., Caesarea, Israel). The type of the measure is continuous and no specified minimum or maximum value. RHI values >1.67 are considered normal, whereas RHI values ≤1.67 are considered abnormal, with higher RHI values indicating better endothelial function.
Measured: 3-months after randomization
24-hours Ambulatory Blood Pressure
Blood pressure will be monitored over a 24-hour period. Mean 24-hour blood pressure will be calculated.
Measured: 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.
Measured: 3-months after randomization
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.
Measured: 3-months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start16 Oct 2020
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Safwan Badr, Wayne State University
- Investigators
- M. Safwan Badr, MD, MBA, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279834
- Sponsor's protocol ID
- 1809001759
- Other IDs
- R01HL146059
- Acronym
- RESTORE
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2020
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No