Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

October 28, 2021 updated by: Johns Hopkins University

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

Recruitment strategies comparing different strategies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Department of Medicine, Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Study Arm 1
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.
Behavioral: Lifestyle Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Fusion Health

Investigators

  • Principal Investigator: Naresh Punjabi, M.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ACTUAL)

May 17, 2021

Study Completion (ACTUAL)

May 17, 2021

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 10, 2019

First Posted (ACTUAL)

June 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00199862

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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