Tailored Treatment to Enhance Risk Perception in Sleep Apnea

NCT02314858 | Completed

• 2 other identifiers: 2809R01HL120693
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Treatment Adherence

  Treatment adherence as measured directly from the participant's PAP device. Adherence is monitored objectively as time at prescribed pressure and daily measures of adherence are transmitted remotely to the study site nightly using a wireless modem. There are several specific adherence measures that will be available from the PAP units. These include the average hours of use per night across all nights, the average hours of use on nights PAP is actually used, and the percentage of nights PAP is used across all nights.

  90 days

Study Arms (3)

Brief Personalized Video (BPV)

EXPERIMENTAL

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.

Behavioral: Brief Personalized Video (BPV)

Non-Personalized Video (NPV)

ACTIVE COMPARATOR

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.

Behavioral: Non-Personalized Video (NPV)

Treatment As Usual (TAU)

PLACEBO COMPARATOR

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

Behavioral: Treatment as Usual (TAU)

Interventions

Brief Personalized Video (BPV) BEHAVIORAL

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

Also known as: BPV

Brief Personalized Video (BPV)

Non-Personalized Video (NPV) BEHAVIORAL

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

Also known as: NPV

Non-Personalized Video (NPV)

Treatment as Usual (TAU) BEHAVIORAL

The TAU group will not watch a video.

Also known as: Standard of Care

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Jewish Health: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Therapeutics; Standard of Care

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mark Aloia, PhD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 11, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: March 1, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

US (1)