CPAP and Behavioral Interventions for Sleep Apnea
(ISAAC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a combined behavioral approach can help individuals with obstructive sleep apnea (OSA) adhere to their CPAP treatment, improving sleep and quality of life. The study compares usual care with a special program that includes remote support, virtual therapy sessions, and peer support for both the patient and their bed partner. Ideal candidates for this trial have moderate or severe OSA, have previously used a CPAP machine, and have a bed partner willing to participate. As an unphased trial, this study provides a unique opportunity to explore innovative support methods that could enhance the treatment experience and quality of life.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this combined behavioral intervention is safe for patients with obstructive sleep apnea?
Research has shown that combined behavioral approaches for sleep apnea are generally safe and easy to manage. These methods help individuals with obstructive sleep apnea (OSA) use their CPAP machines more consistently, incorporating support like remote monitoring, feedback, and partner involvement.
No evidence indicates serious side effects from these approaches. They emphasize education and support to enhance sleep habits and CPAP adherence. One study found that partner involvement increases the likelihood of consistent therapy adherence, leading to more regular CPAP use.
Overall, these combined behavioral approaches are safe, focusing on lifestyle changes and education rather than medications or invasive treatments.12345Why are researchers excited about this trial?
Researchers are excited about the CPAP and Behavioral Interventions for Sleep Apnea trial because it explores a unique, couple-oriented approach to managing obstructive sleep apnea (OSA). Unlike traditional CPAP therapy, which mainly focuses on the individual's compliance, this trial includes the patient's bed partner in the treatment plan. This approach involves CPAP instruction, virtual group sessions, and cognitive behavioral couple therapy, which may enhance adherence and support from partners. By addressing the behavioral and social aspects of OSA treatment, this trial could lead to improved long-term outcomes and patient satisfaction.
What evidence suggests that this combined behavioral intervention is effective for sleep apnea?
Research has shown that using a CPAP machine along with certain behavioral strategies can help people with obstructive sleep apnea (OSA). In this trial, participants in the Couple-oriented Intervention Arm will receive CPAP instruction, participate in virtual group sessions with peers, and engage in cognitive-behavioral couple therapy sessions. Studies have found that adding cognitive-behavioral therapy (CBT) and peer support can help patients use their CPAP machines more regularly. Telemonitoring, which involves remotely checking in on patients and providing feedback, has also led to more consistent CPAP use compared to usual care. In another study, motivational enhancement therapy significantly increased CPAP usage. These combined approaches may improve sleep and overall quality of life for patients and their partners.56789
Who Is on the Research Team?
John Thornton, MD, MPH
Principal Investigator
MetroHealth System, Ohio
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combined behavioral intervention including CPAP education, virtual cognitive behavioral couple therapy, and couple-oriented peer support
Follow-up
Participants are monitored for CPAP adherence, quality of sleep, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Combined Behavioral Intervention
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Patients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following 1. CPAP instruction from sleep technologist 2. 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner 3. Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes 5\. 5 cognitive behavioral couple therapy sessions
Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual.
Find a Clinic Near You
Who Is Running the Clinical Trial?
MetroHealth Medical Center
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Pittsburgh
Collaborator
MetroHealth System, Ohio
Collaborator
Citations
The impact of continuous positive airway pressure ...
Objective: This study aimed to systematically assess the effect of CPAP combined with lifestyle interventions on OSA severity, as measured by ...
Effectiveness of behavioral and psychosocial interventions ...
Effectiveness of behavioral and psychosocial interventions for continuous positive airway pressure adherence among patients with obstructive sleep apnea: A ...
NCT01633827 | Combination Therapy to Treat Sleep Apnea
This research study is being conducted to learn whether using a combination of therapies (i.e. a sedative and oxygen therapy) will improve OSA severity by ...
Effectiveness of behavioral and psychosocial interventions ...
Telemonitoring improved the mean nightly hour of CPAP utilization compared with standard care. Motivational Enhancement Therapy (MET) had the most significant ...
Feasibility and preliminary efficacy results for WePAP
Study objectives: The goal of this study was to examine feasibility, acceptability, and preliminary efficacy of. WePAP, a novel, couples-based treatment to ...
Educational, supportive and behavioural interventions ... - PMC
Educational, supportive and behavioural interventions may help people with OSA initiate and maintain regular and continued use of CPAP.
Effects of combined exercise and sleep hygiene on ...
This randomized controlled trial included adults aged 60–79 years with moderate-to-severe OSA (apnea–hypopnea index ≥ 15 events/hour).
The Improving Sleep in African American Couples Study ...
The goal of this randomized study is to compare a combined behavioral intervention (remote tele-monitoring and feedback, virtual cognitive behavioral couple ...
Three in a Bed: Can Partner Support Improve CPAP ...
This systematic review seeks to consolidate current evidence regarding the impact of partner support on CPAP adherence in individuals with OSAS.
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