Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Completed · Not applicable

Conditions studied: Sleep Disorder, Pre Diabetes, Obstructive Sleep Apnea

In brief

Recruitment strategies comparing different strategies.

Key facts

Study ID

NCT03984058

Run by

Johns Hopkins University

People needed

1

Starts

2019-10-01

Expected to finish

2021-05-17

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Medicine, Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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