Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Johns Hopkins University

Status: Completed

Conditions: Sleep Disorder; Pre Diabetes; Obstructive Sleep Apnea

Treatments: Behavioral: Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03984058

IRB00199862

Details and patient eligibility

About

Recruitment strategies comparing different strategies.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Study Arm 1

Other group

Description:

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.

Treatment:

Behavioral: Lifestyle Intervention