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
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|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
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
|Contact: Ann Depew, LPC||303-398-1149||DepewA@NJHealth.org|
|Contact: Kelly Goelz, MA||303-398-1597||GoelzK@NJHealth.org|
|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|
|Principal Investigator:||Mark Aloia, PhD||National Jewish Health|