Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity

NCT05343000 | Completed Results

• 2 other identifiers: 21-011497R43HL162131
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.

Conditions

Obstructive Sleep Apnea; Obesity

Outcome Measures

Primary Outcomes (3)

• Ability to Use the Devices at Home

  The number of participants who were able to utilize the devices at home.

  2 Weeks

• Usability of Proposed System in Patients With OSA and Obesity

  Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the ease of using the technology on a scale of 1 to 10 (1=very difficult, 10=very easy), with higher scores indicating a better outcome.

  2 Weeks

• Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity

  Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the helpfulness of the setup instructions from 1 to 10 (1=not at all helpful, 10=very helpful), with lower scores indicating a worse outcome.

  2 Weeks

Secondary Outcomes (2)

• Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity

  2 Weeks

• Perceived Benefit of Proposed System in Patients With OSA and Obesity

  2 Weeks

Study Arms (1)

Severe Comorbid OSA

EXPERIMENTAL

Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system

Behavioral: Home-based pulmonary rehabilitation (PR) system

Interventions

Home-based pulmonary rehabilitation (PR) system BEHAVIORAL

Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors upload the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches call patients regularly to celebrate progress, assist with any issues, and set new goals.

Severe Comorbid OSA

Eligibility Criteria

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

You may qualify if:

• Adult patients, 18 years of age or older.
• Diagnosis of Obstructive Sleep Apnea (OSA) and obesity (BMI \> or = to 35).

You may not qualify if:

• Individuals \< 18 years of age.
• Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Minnesota HealthSolutions: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Roberto Benzo, M.D.
• Organization: Mayo Clinic

benzo.roberto@mayo.edu

480-301-8244

Study Officials

• Roberto Benzo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot study

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: February 3, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Locations

US (1)