Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Study Overview
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Brief Summary
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Recruitment strategies comparing different strategies.

Detailed Description
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Patients with prediabetes and moderate-to-severe Obstructive Sleep Apnea (OSA). To determine the recruitment yields from electronic medical record (EMR) vs the general community. To assess the adherence to positive airway pressure (PAP) therapy among patients with prediabetes and moderate-to-severe OSA.

Official Title
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Comparing Recruitment Strategies for a Randomized Controlled Trial in Sleep Apnea and Prediabetes

Conditions
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Sleep Disorder, Pre Diabetes, Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prediabetes: A1c value of 6.0-6.4% and fasting glucose of 100-125 mg/dl 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: BMI < 28 or ≥ 38 kg/m2 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Arm 1<br>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. | Behavioral: Lifestyle Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR) | Determine recruitment yield from EMR versus the general community. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Pap Therapy as assessed by the ResMed AirView Remote Monitoring system | Participants will have PAP usage monitored with the ResMed AirView Remote Monitoring system. An intervention will be required when PAP adherence decreases or if any other issues are identified that require a face-to-face visit. A phone contact or in-person visit will be scheduled if the following findings observed for ≥3 consecutive nights: Suboptimal adherence (< 5 hours per night); Mean leak is high (> 20 L/min); or treatment is not optimal (AHI ≥ 5 events/h) Each participant will have a follow-up visit   7 days after starting PAP therapy | 1 Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-diabetes, Sleep Apnea, PAP Therapy, Obstructive Sleep Apnea