Trial results for a lifestyle program aimed at individuals with Obstructive Sleep Apnea and severe Obesity were posted on ClinicalTrials.gov on 2025-10-16, with 17 participants enrolled. The study focused on developing and assessing a data-driven system for remote monitoring and health coaching.
Background
Obesity is a complex, chronic disease characterized by excessive body fat, which significantly increases the risk of various health complications. Obstructive Sleep Apnea (OSA) is a common and serious comorbidity in individuals with severe obesity, where breathing repeatedly stops and starts during sleep. Both conditions negatively impact overall health, quality of life, and life expectancy. Effective interventions are crucial to manage these intertwined conditions, often requiring comprehensive approaches that promote sustained behavior changes. This study aimed to develop and evaluate a system utilizing remote monitoring and health coaching to improve health and quality of life for persons with severe obesity and sleep apnea.
Trial design
This completed study, designated as Phase NA, enrolled 17 participants to investigate conditions including Obstructive Sleep Apnea and Obesity. The trial's purpose was to develop a data-driven system for individuals with severe obesity and sleep apnea, utilizing remote monitoring with health coaching to foster behavior changes aimed at improving health and quality of life. The study assessed various aspects of the proposed system, including its usability and perceived benefit among participants.
Key results
The trial reported several key measurements related to the usability and perception of the proposed system:
- The Ability to Use the Devices at Home was reported by 15 Participants.
- The Usability of Proposed System in Patients With OSA and Obesity showed a mean score of 9.5 on a scale.
- The Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity showed a mean score of 9.2 on a scale.
- Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity was reported by 15 Participants.
- The Perceived Benefit of Proposed System in Patients With OSA and Obesity was reported by 15 Participants.
What this means
The results indicate positive user experience and acceptance for the proposed data-driven system involving remote monitoring and health coaching for individuals with severe obesity and obstructive sleep apnea. High scores for usability and helpfulness, alongside a significant number of participants reporting confidence and perceived benefit, suggest that such a system could be a valuable tool in promoting health behavior changes. While these findings are from a small-scale study with 17 participants, they provide initial evidence of the system's potential and user satisfaction, laying groundwork for further development and larger clinical investigations into its efficacy in improving health outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05343000, titled "Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity", were posted on 2025-10-16 on clinicaltrials.gov.