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Tailored Treatment to Enhance Risk Perception in Sleep Apnea

NCT02314858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2021-06-30

No results posted yet for this study

Summary

Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious medical condition with significant medical and psychological consequences, including diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is Positive Airway Pressure therapy (PAP). PAP supplies positive pressure to the upper airway creating a "pneumatic splint" to keep the airway open during sleep. Adherence to PAP is notoriously low, with as few as 50% reaching minimal guidelines for adherence. One comprehensive review of adherence research found that adherence to PAP was less than that for any other medical disorder. The problem of adherence is significant not only because of the medical consequences that can ensue, but also because third party payers have begun to refuse to pay for PAP therapy when adherence is less than optimal, even in the face of clinical improvement. This is a critical time to address this problem.

This research study is designed to identify methods that may help people respond to PAP, the most common therapy for OSA. Identifying these methods may be an important way to better care for patients with obstructive sleep apnea. With this research, the investigators hope to find ways to help people have a better response to treatment and a better quality of life.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

BEHAVIORAL

Brief Personalized Video (BPV)

The BPV group will view a portion of their own sleep study that took place during their overnight sleep study.

BEHAVIORAL

Non-Personalized Video (NPV)

The NPV group will see a stock video of someone with OSA.

BEHAVIORAL

Treatment as Usual (TAU)

The TAU group will not watch a video.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

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

    collaborator NIH

  • National Jewish Health

    lead OTHER

Principal Investigators

  • Mark Aloia, PhD · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2020-04-30
Completion
2021-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314858 on ClinicalTrials.gov