Tailored Treatment to Enhance Risk Perception in Sleep Apnea

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea (OSA)

In brief

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.

Key facts

Study ID

NCT02314858

Run by

National Jewish Health

People needed

284

Starts

2014-10-01

Expected to finish

2021-03-01

Last updated by the study team

2021-06-30

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• National Jewish Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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