NCT06621511 · National Heart, Lung, and Blood Institute (NHLBI)
OurSleepKit To Support CPAP Adherence
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where
- Boston, Massachusetts
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 3, 2026 · Source of record for eligibility and locations