Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes
NCT ID: NCT03984058
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2019-10-01
2021-05-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Study Arm 1
All enrolled participants will have participants' PAP usage monitored by Fusion Health using the ResMed AirView Remote Monitoring system. Fusion Health will provide individual care for each participant by monitoring daily PAP usage by all study participants. This assessment ensures routine follow-up of PAP adherence during the study. The responsibility for patient care during the study, however, will fall on clinical site staff with any needed assistance by the Fusion Health staff. An intervention will be required when PAP adherence decreases or if any other issues are identified that require a face-to-face visit.
Lifestyle Intervention
A lifestyle intervention program adapted from the Diabetes Prevention Program (DPP). Study participants will start lifestyle intervention on the day of initiating PAP therapy. The 3-month program will be followed: Patient-facing Online Platform: The program will be accessible to study participant via the Web or a Web application available for the Android and iOS devices. Behavioral Weight Loss Goals and Lessons: The program begins with an introductory session that presents the basic goals for the program followed by 12 weekly multimedia lessons. Submission of self-monitoring data: Participants will submit daily weight, caloric intake, and physical activity minutes at least weekly to the study website for 12 weeks. Automated Feedback: In response to the self-monitoring data, participants receive a weekly automated message that compares participants' self-reported values to participants' goals for weekly and overall weight loss, caloric intake, and physical activity minutes.
Interventions
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Lifestyle Intervention
A lifestyle intervention program adapted from the Diabetes Prevention Program (DPP). Study participants will start lifestyle intervention on the day of initiating PAP therapy. The 3-month program will be followed: Patient-facing Online Platform: The program will be accessible to study participant via the Web or a Web application available for the Android and iOS devices. Behavioral Weight Loss Goals and Lessons: The program begins with an introductory session that presents the basic goals for the program followed by 12 weekly multimedia lessons. Submission of self-monitoring data: Participants will submit daily weight, caloric intake, and physical activity minutes at least weekly to the study website for 12 weeks. Automated Feedback: In response to the self-monitoring data, participants receive a weekly automated message that compares participants' self-reported values to participants' goals for weekly and overall weight loss, caloric intake, and physical activity minutes.
Eligibility Criteria
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Inclusion Criteria
* Moderate-to-severe OSA \[4% oxygen desaturation index (ODI) ≥ 20/h\]
* Ability to provide informed consent
* Able to comply with all study procedures and be available for the study duration
* Availability of smart phone
Exclusion Criteria
* Type 1 or Type 2 diabetes mellitus
* Pregnancy
* Use of glucose-lowering or weight loss medications (e.g., metformin, orlistat, phentermine)
* Prior or anticipated bariatric surgery
* Current use of PAP or oral appliance therapy for OSA
* Commercial driver
* Report of a motor vehicle accident or near-miss due to sleepiness within 2 years
* Epworth Sleepiness Scale score10 \> 18
* Current (prevalent) use of oral corticosteroids (within 1 month)
* Participation in a concurrent clinical trial
* Unstable medical conditions: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension \[BP ≥ 160/100 among those with hypertension, requiring 3 or more meds\], severe chronic obstructive pulmonary disease, cancer, or active psychiatric disease
* Other sleep disorders (e.g., circadian rhythm disorder, working night or rotation shift, short sleep duration based on self-reported habitual sleep patterns \< 5 hrs/night)
* Use of supplemental oxygen during wakefulness or sleep
* Central sleep apnea (central apnea index ≥ 5/h) or Cheyne-Stokes respiration (\> 10 minutes of continues period breathing) on the screening home sleep test Resting awake SpO2 \< 90%
* Chronic opiate use.
* Use of illicit drug / marijuana use more than once per week
* Difficulty understanding or speaking English
* Anything that, in the opinion of the site investigator, would place the participant at increased risk or preclude a participant's ability to adhere to study protocols or complete the study
18 Years
70 Years
ALL
No
Sponsors
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Fusion Health
UNKNOWN
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Naresh Punjabi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Department of Medicine, Johns Hopkins University
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00199862
Identifier Type: -
Identifier Source: org_study_id