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Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

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ClinicalTrials.gov Identifier: NCT03984058
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Fusion Health
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Recruitment strategies comparing different strategies.

Condition or disease Intervention/treatment Phase
Sleep Disorder Pre Diabetes Obstructive Sleep Apnea Behavioral: Lifestyle Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparing Recruitment Strategies for a Randomized Controlled Trial in Sleep Apnea and Prediabetes
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984058


Contacts
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Contact: Naresh Punjabi, M.D. 410-550-2632 npunjabi@jhmi.edu
Contact: Joseph Carrese, M.D. 4105022092 jhmeirb@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Fusion Health
Investigators
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Principal Investigator: Naresh Punjabi, M.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03984058     History of Changes
Other Study ID Numbers: IRB00199862
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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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

Keywords provided by Johns Hopkins University:
Pre-diabetes
Sleep Apnea
PAP Therapy
Obstructive Sleep Apnea

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Wake Disorders
Parasomnias
Prediabetic State
Glucose Intolerance
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia