Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Not Applicable

Completed

• Conditions: Sleep Disorder; Pre Diabetes; Obstructive Sleep Apnea
• Interventions: Behavioral: Lifestyle Intervention

• Registration Number: NCT03984058
• Lead Sponsor: Johns Hopkins University

Brief Summary

Recruitment strategies comparing different strategies.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Study Start: 2019-10-01
• Status Verified: 2020-11
• Primary Completion: 2021-05-17
• Study Completion: 2021-05-17
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm 1	Lifestyle Intervention	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.

Primary Outcome Measures

Name	Time	Method
Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR)	1 year	Determine recruitment yield from EMR versus the general community.

Secondary Outcome Measures

Name	Time	Method
Adherence to Pap Therapy as assessed by the ResMed AirView Remote Monitoring system	1 Week	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

Trial Locations

Locations (1)

Department of Medicine, Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States