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Tailored Treatment to Enhance Risk Perception in Sleep Apnea

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ClinicalTrials.gov Identifier: NCT02314858
Recruitment Status : Unknown
Verified June 2016 by National Jewish Health.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE December 8, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02314858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tailored Treatment to Enhance Risk Perception in Sleep Apnea
Official Title  ICMJE Tailored Treatment to Enhance Risk Perception in Sleep Apnea.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea (OSA)
Intervention  ICMJE
  • 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
  • Behavioral: Non-Personalized Video (NPV)
    The NPV group will see a stock video of someone with OSA.
    Other Name: NPV
  • Behavioral: Treatment as Usual (TAU)
    The TAU group will not watch a video.
    Other Name: Standard of Care
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Brief Personalized Video (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.
    Intervention: Behavioral: Non-Personalized Video (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.
    Intervention: Behavioral: Treatment as Usual (TAU)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 10, 2014)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02314858
Other Study ID Numbers  ICMJE 2809
R01HL120693 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Jewish Health
Study Sponsor  ICMJE National Jewish Health
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Mark Aloia, PhD National Jewish Health
PRS Account National Jewish Health
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP