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Tailored Treatment to Enhance Risk Perception in Sleep Apnea

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ClinicalTrials.gov Identifier: NCT02314858
Recruitment Status : Recruiting
First Posted : December 11, 2014
Last Update Posted : June 23, 2016
Sponsor:
Collaborators:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

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.



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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02314858


Contacts
Contact: Ann Depew, LPC 303-398-1149 DepewA@NJHealth.org
Contact: Kelly Goelz, MA 303-398-1597 GoelzK@NJHealth.org

Locations
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Ann Depew, LPC    303-398-1149    DepewA@NJHealth.org   
Contact: Kelly Goelz, MA    303-398-1597    GoelzK@NJHealth.org   
Principal Investigator: Mark Aloia, PhD         
Sub-Investigator: Jack Edinger, PhD         
Sub-Investigator: Belinda Borrelli, PhD         
Sub-Investigator: John Harrington, MD         
Sponsors and Collaborators
National Jewish Health
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Mark Aloia, PhD National Jewish Health

Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT02314858     History of Changes
Other Study ID Numbers: 2809
R01HL120693 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases