Tailored Treatment to Enhance Risk Perception in Sleep Apnea

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

Tailored Treatment to Enhance Risk Perception in Sleep Apnea.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314858
• Other study ID #: 2809
• Secondary ID: R01HL120693
• Status: Completed
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: March 2021

Study information

• Verified date: June 2021
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: March 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• Non-Personalized Video (NPV)
The NPV group will see a stock video of someone with OSA.
• Treatment as Usual (TAU)
The TAU group will not watch a video.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
National Jewish Health	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Adherence	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.	90 days