Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

NCT03984058 | Completed

• 1 other identifier: IRB00199862
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Recruitment strategies comparing different strategies.

Conditions

Sleep Disorder; Pre Diabetes; Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Determine recruitment yield from EMR versus the general community.

  1 year

Secondary Outcomes (1)

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

  1 Week

Study Arms (1)

Study Arm 1

OTHER

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

Interventions

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.

Study Arm 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Johns Hopkins University: lead
• Fusion Health: collaborator

Study Sites (1)

Department of Medicine, Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Glucose Intolerance; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Naresh Punjabi, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: October 1, 2019
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: October 29, 2021

Record last verified: 2020-11

Locations

US (1)