RECRUITING

OurSleepKit to Support CPAP Adherence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

OurSleepKit: a Couple-focused M-Health Intervention to Support Adherence to CPAP Treatment

Quick Facts

Study Start:2024-12-03
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06621511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * The partners of eligible patients will be recruited if they are not diagnosed with OSA and not using CPAP
  3. * both partners should have their own mobile devices with access to the internet
  1. * 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)
  2. * have planned bariatric surgery (as they typically quit CPAP after surgery)
  3. * have a partner using CPAP
  4. * are pregnant because the changes in respiration and sleep quality occurring with pregnancy may confound the results.
  5. * couples with one or both partners doing regular overnight shift work or those unable to speak or write in English will be excluded.

Contacts and Locations

Study Contact

Lichuan Ye, PhD
CONTACT
617-373-2582
l.ye@northeastern.edu
Jack Johnson, BS
CONTACT
5082460704
jac.johnson@northeastern.edu

Study Locations (Sites)

Northeastern University
Boston, Massachusetts, 02115
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-03
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-12-03
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

  • Obstructive Sleep Apnea
  • CPAP Treatment
  • Mobile Health
  • Treatment Adherence
  • Dyadic Coping
  • Couple

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea
  • CPAP Treatment
  • Treatment Adherence