Trial Outcomes & Findings for Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity (NCT NCT05343000)

NCT ID: NCT05343000

Last Updated: 2025-10-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

2 Weeks

Results posted on

2025-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Severe Comorbid OSA Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: 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.
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Severe Comorbid OSA Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: 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.
Overall Study Physician Decision	2

Baseline Characteristics

Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Severe Comorbid OSA n=17 Participants Newly-diagnosed severe comorbid obstructive sleep apnea subjects used technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors uploaded 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 called patients regularly to celebrate progress, assist with any issues, and set new goals.
Age, Continuous	54.76 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Weeks

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

Outcome measures

Outcome measures
Measure	Severe Comorbid OSA n=15 Participants Newly-diagnosed severe comorbid obstructive sleep apnea subjects used technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors uploaded 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 called patients regularly to celebrate progress, assist with any issues, and set new goals.
Ability to Use the Devices at Home	15 Participants

PRIMARY outcome

Timeframe: 2 Weeks

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.

Outcome measures

Outcome measures
Measure	Severe Comorbid OSA n=15 Participants Newly-diagnosed severe comorbid obstructive sleep apnea subjects used technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors uploaded 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 called patients regularly to celebrate progress, assist with any issues, and set new goals.
Usability of Proposed System in Patients With OSA and Obesity	9.5 score on a scale Interval 1.0 to 10.0

PRIMARY outcome

Timeframe: 2 Weeks

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.

Outcome measures

Outcome measures
Measure	Severe Comorbid OSA n=15 Participants Newly-diagnosed severe comorbid obstructive sleep apnea subjects used technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors uploaded 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 called patients regularly to celebrate progress, assist with any issues, and set new goals.
Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity	9.2 score on a scale Interval 1.0 to 10.0

SECONDARY outcome

Timeframe: 2 Weeks

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. The number of participants who rated their confidence in using the proposed system greater than a 6 on a 10-point scale. The scale ranged from 1=not confident to 10=very confident, with higher scores indicating greater confidence.

Outcome measures

Outcome measures
Measure	Severe Comorbid OSA n=15 Participants Newly-diagnosed severe comorbid obstructive sleep apnea subjects used technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors uploaded 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 called patients regularly to celebrate progress, assist with any issues, and set new goals.
Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity	15 Participants

SECONDARY outcome

Timeframe: 2 Weeks

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. The number of participants who rated their perceived benefit from the system greater than a 7 on a 10-point scale. The scale ranged from 1=not beneficial to 10=very beneficial, with higher scores indicating greater benefit.

Outcome measures

Outcome measures
Measure	Severe Comorbid OSA n=15 Participants Newly-diagnosed severe comorbid obstructive sleep apnea subjects used technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors uploaded 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 called patients regularly to celebrate progress, assist with any issues, and set new goals.
Perceived Benefit of Proposed System in Patients With OSA and Obesity	15 Participants

Adverse Events

Severe Comorbid OSA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberto Benzo, M.D.

Mayo Clinic

Phone: 480-301-8244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place