Tailored Treatment to Enhance Risk Perception in Sleep Apnea

NCT ID: NCT02314858

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2021-03-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brief Personalized Video (BPV)

Our BPV intervention focuses on augmenting risk perception and reducing optimistic bias by showing the patient a dramatic video of his/her own apnea (which shows them struggle to breathe), as well as by explaining the physiological processes involved in an apneic event. Specific apneic events are highlighted and associated decreases in blood oxygen levels are demonstrated via oxygen saturation recording superimposed on the video. This group will receive educational information about OSA, its consequences and the need for treatment.

Group Type: EXPERIMENTAL

Brief Personalized Video (BPV)

Intervention Type: BEHAVIORAL

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

Non-Personalized Video (NPV)

NPV will include a video of someone having apnea, but it will not be personalized. This group will receive educational information about OSA, its consequences and the need for treatment.

Group Type: ACTIVE_COMPARATOR

Non-Personalized Video (NPV)

Intervention Type: BEHAVIORAL

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

Treatment As Usual (TAU)

The TAU group will receive no special treatment from study interventionist team and will not view a video.

Group Type: PLACEBO_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

The TAU group will not watch a video.

Interventions

Brief Personalized Video (BPV)

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

Intervention Type: BEHAVIORAL

Non-Personalized Video (NPV)

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

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

The TAU group will not watch a video.

Intervention Type: BEHAVIORAL

Other Intervention Names

BPV; NPV; Standard of Care

Eligibility Criteria

Inclusion Criteria

• Polysomnography (PSG) confirmed diagnosis of Obstructive Sleep Apnea (OSA)
• choice of PAP as preferred treatment
• judged by sleep physicians to be responders to PAP
• participants will be considered responders to PAP if they have an AHI of less than 5, do not snore, and have an arousal index of less than 10 when titrated to the proper pressure of PAP

Exclusion Criteria

• Apnea-Hypopnea Index (AHI) < 15 on the diagnostic PSG and no daytime functional symptoms or associated cardiovascular disease
• a sleep disorder other than OSA that causes arousals from sleep (e.g., periodic limb movements, restless legs syndrome, insomnia)
• a current substance abuse problem
• a serious sleep-disruptive medical condition (e.g., end stage renal failure, severe Chronic Obstructive Pulmonary Disease (COPD), severe asthma)
• significant global cognitive impairment
• history of or current diagnosis of psychosis, bipolar disorder, or borderline, schizotypal or antisocial personality disorder, and uncontrolled depression or suicidal ideation
• change in antidepressant medications over the past 3 months
• women pregnant women, breast feeding, or planning on becoming pregnant
• currently enrolled in another research study

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Aloia, PhD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

National Jewish Health

Denver, Colorado, United States

Countries

United States

Other Identifiers

R01HL120693

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2809

Identifier Type: -

Identifier Source: org_study_id