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Tailored Treatment to Enhance Risk Perception in Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02314858
Recruitment Status : Active, not recruiting
First Posted : December 11, 2014
Last Update Posted : September 9, 2020
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Jewish Health

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea (OSA) Behavioral: Brief Personalized Video (BPV) Behavioral: Non-Personalized Video (NPV) Behavioral: Treatment as Usual (TAU) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Tailored Treatment to Enhance Risk Perception in Sleep Apnea.
Study Start Date : October 2014
Actual Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: BPV

Active Comparator: 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.
Behavioral: Non-Personalized Video (NPV)
The NPV group will see a stock video of someone with OSA.
Other Name: NPV

Placebo Comparator: Treatment As Usual (TAU)
The TAU group will receive no special treatment from study interventionist team and will not view a video.
Behavioral: Treatment as Usual (TAU)
The TAU group will not watch a video.
Other Name: Standard of Care

Primary Outcome Measures :
  1. Treatment Adherence [ Time Frame: 90 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02314858

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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Mark Aloia, PhD National Jewish Health
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Responsible Party: National Jewish Health Identifier: NCT02314858    
Other Study ID Numbers: 2809
R01HL120693 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases