Obstructive Sleep ApneaNCT06621511
OurSleepKit To Support CPAP Adherence
A study testing OurSleepKit in people with Obstructive Sleep Apnea and CPAP Treatment, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn if a couple-focused mobile health intervention will improve the use of continuous positive airway pressure (CPAP), the primary treatment option for obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, CPAP Treatment, Treatment Adherence
- What is being tested?
- OurSleepKit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Dec 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients should be males or females (age≥18 years) with diagnosed OSA and candidates for CPAP therapy (with any type of pressure delivery mode), and are cohabiting with their partner for at least one year
- The partners of eligible patients will be recruited if they are not diagnosed with OSA and not using CPAP
- both partners should have their own mobile devices with access to the internet
Who cannot join
- have a diagnosis of a sleep disorder other than OSA based on a polysomnogram (e.g., central sleep apnea, narcolepsy, or periodic limb movement disorder)
- have planned bariatric surgery (as they typically quit CPAP after surgery)
- have a partner using CPAP
- are pregnant because the changes in respiration and sleep quality occurring with pregnancy may confound the results.
- couples with one or both partners doing regular overnight shift work or those unable to speak or write in English will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Northeastern University
Boston, Massachusetts, 02115
Lichuan Ye, PhD, 617-373-2582, l.ye@northeastern.edu
Jack johnson, BS, 5082460704, jac.johnson@northeastern.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Sanjay Patel, MD, patelsr2@upmc.edu
Sanjay Patel, MD
About this study
Official title: OurSleepKit: A Couple-focused m-Health Intervention to Support Adherence to CPAP Treatment
The goal of this clinical trial is to learn if a couple-focused mobile health intervention will improve the use of continuous positive airway pressure (CPAP), the primary treatment option for obstructive sleep apnea (OSA). Participants include newly diagnosed patients with OSA who are candidates for CPAP treatment and their partners. The couples will received supportive information and resources on their mobile devices before CPAP begins and continuing for 6 months into CPAP treatment. Their interaction with the resources is self-paced and the time sent engaging with the information is up to them. Participants will be asked to answer questions independently at five points: before CPAP, and after using CPAP for 1-week, 1-month, 3-months and 6-months. Those questions are about their experience of using CPAP, how the partner is involved in CPAP treatment, and symptoms and quality of life. At the end of the study, some couples may be contacted for a virtual discussion about your experience regarding study participation which lasts approximately 1 hour.
- Conditions
- Obstructive Sleep Apnea, CPAP Treatment, Treatment Adherence
- Being tested
- OurSleepKit
- Keywords
- Obstructive Sleep Apnea, CPAP Treatment, Mobile Health, Treatment Adherence, Dyadic Coping, Couple
- Medical subject headings
- Sleep Apnea, Obstructive, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OurSleepKitBehavioural
OurSleepKit is developed as an app including a patient version and a partner version, to be downloaded on the patient's or partner's mobile devices at home. The goal of OurSleepKit is to coach mutual engagement and model positive partner involvement in CPAP treatment, thus motivating greater CPAP adherence. Using OurSleepKit, both the patient and partner will complete periodic assessments tracking various aspects of their sleep and CPAP use. The assessment data are then processed by OurSleepKit to provide customized and dynamically updated support content consisting of brief story-telling videos featuring real-life couples' experiences emphasizing positive dyadic coping and problem-solving strategies. OurSleepKit delivers timely tailored prompts through push notifications on the users' mobile devices' screens, linked to relevant support content, to facilitate positive conversation in the dyad and offer in-the-moment support for CPAP use.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Couples in the intervention group will have exposure to the OurSleepKit app in addition to usual care. |
| Control group | No intervention | Couples in the control group will not have exposure to the OurSleepKit app during the trial. Patients will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP adherence
Average hours of nightly CPAP use over the course of the first six months of treatment
Measured: 6 months
Secondary outcomes (7)
Self-efficacy
Self-Efficacy Measure for Sleep Apnea (SEMSA) is a 26-item validated instrument that contains 3 subscales: risk perception of OSA, outcome expectancies of CPAP, and treatment self-efficacy. Internal consistency was reported as 0.90 for the total scale and 0.85 to 0.89 for the 3 subscales. Reported test-retested reliabilities ranged from 0.68 to 0.77.96
Measured: 6 months
Functional Status
Functional Outcomes of Sleep Questionnaire (FOSQ) is a 30-item disease-specific measure to assess the impact of excessive daytime sleepiness on activities of daily living. It includes five subscales: activity level, vigilance, intimacy and sexual relationships, general productivity, and social outcomes. The potential range for each subscale is 1-4, with a total score of 5-20. Higher scores on the FOSQ indicate better daily functioning. The FOSQ has established content validity, test-retest reliability (0.90), internal consistency (0.96), and concurrent validity with standardized generic measures of functional status.
Measured: 6 months
Health-Related Quality of life
Quality of life will be measured by the 12-item Short Form Health Survey (SF-12). The SF-12 is a validated short form survey with 12 questions selected from the SF-36 Health Survey. The questions are scored to provide evaluations into mental and physical functioning and overall health-related quality of life.
Measured: 6 months
Dyadic Coping
The Dyadic Coping Inventory (DCI) is a 37-item questionnaire that assesses stress communication and dyadic coping as perceived by each partner about his or her own coping, each partner's perception of the other's coping, and each partner's view of how they cope as a couple on a scale from 1 (very rarely) to 5 (very often). There are four subscales measuring types of dyadic coping: delegated, supportive, stress communication, and negative dyadic coping.
Measured: 6 months
Daytime Sleepiness
Epworth Sleepiness Scale (ESS) includes items about the likelihood of falling asleep in eight soporific situations. The ESS significantly correlates with the frequency of apneic episodes and is a clinical and research standard in the assessment of daytime sleepiness. It has high test-retest reliability (0.82) and internal consistency (0.88).
Measured: 6 months
Sleep Quality and Sleep-related Impairment
Patient-Reported Outcomes Information System (PROMIS®) assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.The PROMIS Sleep-Related Impairment focuses on self- reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Both tools can readily discriminate patient and control groups, and are sensitive to treatment.
Measured: 6 months
Partner Involvement in CPAP Treatment
A brief questionnaire with 6 validated items will be used, including three subscales: pressure (asked about using CPAP, tried to persuade you to use CPAP, dropped hints about using CPAP), collaboration (helped solve a problem with CPAP, helped with the CPAP machine), and support (felt supported for using CPAP) on a scale from 1 (not at all) to 5 (extreme). We have used paired versions (one for patient and one for partner) for dyadic evaluation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start3 Dec 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621511
- Sponsor's protocol ID
- IRB #: 24-04-26
- Other IDs
- R01HL160836
- Status last verified
- Jan 2026
- First submitted
- 27 Sep 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will be shared per NIH policy after the completion and publication of the main analyses. The final research data will not contain any patient identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OurSleepKit: A Couple-focused m-Health Intervention to Support Adherence to CPAP Treatment
- ClinicalTrials.gov ID
- NCT06621511
- Acronym / sponsor ID
- IRB #: 24-04-26
- Conditions
- Obstructive Sleep Apnea, CPAP Treatment, Treatment Adherence
- Keywords
- Obstructive Sleep Apnea, CPAP Treatment, Mobile Health, Treatment Adherence, Dyadic Coping, Couple
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a couple-focused mobile health intervention will improve the use of continuous positive airway pressure (CPAP), the primary treatment option for obstructive sleep apnea (OSA). Participants include newly diagnosed patients with OSA who are candidates for CPAP treatment and their partners. The couples will received supportive information and resources on their mobile devices before CPAP begins and continuing for 6 months into CPAP treatment. Their interaction with the resources is self-paced and the time sent engaging with the information is up to them. Participants will be asked to answer questions independently at five points: before CPAP, and after using CPAP for 1-week, 1-month, 3-months and 6-months. Those questions are about their experience of using CPAP, how the partner is involved in CPAP treatment, and symptoms and quality of life. At the end of the study, some couples may be contacted for a virtual discussion about your experience regarding study participation which lasts approximately 1 hour.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | –Couples in the intervention group will have exposure to the OurSleepKit app in addition to usual care. |
| Control group | No intervention | –Couples in the control group will not have exposure to the OurSleepKit app during the trial. Patients will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients should be males or females (age≥18 years) with diagnosed OSA and candidates for CPAP therapy (with any type of pressure delivery mode), and are cohabiting with their partner for at least one year
- The partners of eligible patients will be recruited if they are not diagnosed with OSA and not using CPAP
- both partners should have their own mobile devices with access to the internet
Key exclusion criteria (5 listed)
- have a diagnosis of a sleep disorder other than OSA based on a polysomnogram (e.g., central sleep apnea, narcolepsy, or periodic limb movement disorder)
- have planned bariatric surgery (as they typically quit CPAP after surgery)
- have a partner using CPAP
- are pregnant because the changes in respiration and sleep quality occurring with pregnancy may confound the results.
- couples with one or both partners doing regular overnight shift work or those unable to speak or write in English will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OurSleepKitOurSleepKit is developed as an app including a patient version and a partner version, to be downloaded on the patient's or partner's mobile devices at home. The goal of OurSleepKit is to coach mutual engagement and model positive partner involvement in CPAP treatment, thus motivating greater CPAP adherence. Using OurSleepKit, both the patient and partner will complete periodic assessments tracking various aspects of their sleep and CPAP use. The assessment data are then processed by OurSleepKit to provide customized and dynamically updated support content consisting of brief story-telling videos featuring real-life couples' experiences emphasizing positive dyadic coping and problem-solving strategies. OurSleepKit delivers timely tailored prompts through push notifications on the users' mobile devices' screens, linked to relevant support content, to facilitate positive conversation in the dyad and offer in-the-moment support for CPAP use. | Behavioural | – |
Primary outcome
CPAP adherence
Time frame: 6 months
Average hours of nightly CPAP use over the course of the first six months of treatment
7 secondary outcomes
Self-efficacy
Time frame: 6 months
Functional Status
Time frame: 6 months
Health-Related Quality of life
Time frame: 6 months
Dyadic Coping
Time frame: 6 months
Daytime Sleepiness
Time frame: 6 months
Sleep Quality and Sleep-related Impairment
Time frame: 6 months
Partner Involvement in CPAP Treatment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. The final dataset will be shared per NIH policy after the completion and publication of the main analyses. The final research data will not contain any patient identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OurSleepKit in people with Obstructive Sleep Apnea and CPAP Treatment, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lichuan Ye, PhD (617-373-2582, l.ye@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.