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Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Primary Purpose

Sleep Disorder, Pre Diabetes, Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lifestyle Intervention

About this trial

This is an interventional prevention trial for Sleep Disorder focused on measuring Pre-diabetes, Sleep Apnea, PAP Therapy, Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Medicine, Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Arm 1

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Determine recruitment yield from EMR versus the general community.

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT03984058

First Posted

June 10, 2019

Last Updated

October 28, 2021

Sponsor

Johns Hopkins University

Collaborators

Fusion Health

1. Study Identification

Unique Protocol Identification Number

NCT03984058

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

May 17, 2021 (Actual)

Study Completion Date

May 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

Fusion Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disorder, Pre Diabetes, Obstructive Sleep Apnea

Keywords

Pre-diabetes, Sleep Apnea, PAP Therapy, Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Arm 1

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle Intervention

Intervention Description

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 Measure Information:

Title

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

Description

Determine recruitment yield from EMR versus the general community.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

1 Week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naresh Punjabi, M.D.

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Medicine, Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

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Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

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