search
Back to results

Tailored Treatment to Enhance Risk Perception in Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Personalized Video (BPV)
Non-Personalized Video (NPV)
Treatment as Usual (TAU)
Sponsored by
National Jewish Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Jewish Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Brief Personalized Video (BPV)

Non-Personalized Video (NPV)

Treatment As Usual (TAU)

Arm Description

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.

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.

The TAU group will receive no special treatment from study interventionist team and will not view a video.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2014
Last Updated
June 29, 2021
Sponsor
National Jewish Health
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT02314858
Brief Title
Tailored Treatment to Enhance Risk Perception in Sleep Apnea
Official Title
Tailored Treatment to Enhance Risk Perception in Sleep Apnea.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Personalized Video (BPV)
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Personalized Video (NPV)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment As Usual (TAU)
Arm Type
Placebo Comparator
Arm Description
The TAU group will receive no special treatment from study interventionist team and will not view a video.
Intervention Type
Behavioral
Intervention Name(s)
Brief Personalized Video (BPV)
Other Intervention Name(s)
BPV
Intervention Description
The BPV group will view a portion of their own sleep study that took place during their overnight sleep study.
Intervention Type
Behavioral
Intervention Name(s)
Non-Personalized Video (NPV)
Other Intervention Name(s)
NPV
Intervention Description
The NPV group will see a stock video of someone with OSA.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Other Intervention Name(s)
Standard of Care
Intervention Description
The TAU group will not watch a video.
Primary Outcome Measure Information:
Title
Treatment Adherence
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Aloia, PhD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Tailored Treatment to Enhance Risk Perception in Sleep Apnea

We'll reach out to this number within 24 hrs