Clinical trial NCT03984058: Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes
Official title: Comparing Recruitment Strategies for a Randomized Controlled Trial in Sleep Apnea and Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Pre Diabetes
Obstructive Sleep Apnea
Keywords: Pre-diabetes
Sleep Apnea
PAP Therapy
Obstructive Sleep Apnea
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Fusion Health
First posted: 2019-06-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR)
timeFrame: 1 year
Secondary outcomes:
measure: Adherence to Pap Therapy as assessed by the ResMed AirView Remote Monitoring system
timeFrame: 1 Week
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Department of Medicine, Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Naresh Punjabi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: