OurSleepKit To Support CPAP Adherence

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Treatment Adherence; CPAP Treatment
• Intervention / Treatment: Behavioral: OurSleepKit

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lichuan Ye, PhD; Phone Number: 617-373-2582; Email: l.ye@northeastern.edu
• Study Contact Backup: Name: Jack johnson, BS; Phone Number: 5082460704; Email: jac.johnson@northeastern.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Northeastern University
      • Contact: Lichuan Ye, PhD; Phone Number: 617-373-2582; Email: l.ye@northeastern.edu
      • Contact: Jack johnson, BS; Phone Number: 5082460704; Email: jac.johnson@northeastern.edu
      • Principal Investigator: Lichuan Ye, PhD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Principal Investigator: Sanjay Patel, MD
      • Contact: Sanjay Patel, MD; Email: patelsr2@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Couples in the intervention group will have exposure to the OurSleepKit app in addition to usual care.	Behavioral: OurSleepKit; 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.
No Intervention: Control group; Couples in the control group will not have exposure to the OurSleepKit app during the trial. Patients will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP adherence	Average hours of nightly CPAP use over the course of the first six months of treatment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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).	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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Mobile Health; Treatment Adherence; Couple; Dyadic Coping; CPAP Treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Behavior; Health Behavior; Sleep Apnea, Obstructive; Treatment Adherence and Compliance
• Other Study ID Numbers: IRB #: 24-04-26; R01HL160836 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No