Clinical trial NCT02314858: Tailored Treatment to Enhance Risk Perception in Sleep Apnea
Official title: Tailored Treatment to Enhance Risk Perception in Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-12-11
Enrollment: 284
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Treatment Adherence
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Mark Aloia, PhD
role: PRINCIPAL_INVESTIGATOR
References: