| NCT ID | NCT06621511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2024-12-03 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06621511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06621511 currently recruiting?
Yes, NCT06621511 is actively recruiting participants. Contact the research team at l.ye@northeastern.edu for enrollment information.
Where is the NCT06621511 trial being conducted?
This trial is being conducted at Boston, United States, Pittsburgh, United States.
Who is sponsoring the NCT06621511 clinical trial?
NCT06621511 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 360 participants.