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OpenTrials
Completed

NCT Number: NCT03984058

Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Recruitment strategies comparing different strategies.

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Key information

Conditions

Sleep Disorder Apnea Dyssomnias Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Mental Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Obstructive Sleep Apnea Pathological Conditions, Signs and Symptoms Pre Diabetes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Johns Hopkins University

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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.

Primary outcomes

  1. Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR)

    Time frame: 1 year

    Determine recruitment yield from EMR versus the general community.

Secondary outcomes

  1. Adherence to Pap Therapy as assessed by the ResMed AirView Remote Monitoring system

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Fusion Health

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2019
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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