NCT06144892

The Comfort of Proactive Sleep Apnea Therapy

Comparing the Comfort and Effectiveness of Proactive Airway Management Therapy for Sleep Apnea

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: NovaResp Technologies Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare in OSA patients who regularly adhere to CPAP therapy. The main question\[s\] it aims to answer are: * To assess if proactive therapy can effectively treat OSA with lower mean therapy pressure compared to conventional APAP therapy * To compare user comfort between proactive therapy and conventional APAP therapy Participants will undergo the conventional APAP therapy and the new proactive therapy. Researchers will compare nights in which conventional APAP was used and nights in which proactive therapy was used to see if patients were treated with lower pressures and effectively.

Detailed description

This is a blinded, randomised, crossover, study on patients diagnosed with obstructive sleep apnea who regularly adhere to APAP therapy. Data collection will span 23 consecutive nights for each participant. Participants will use a modified APAP device for 2 periods of 9 nights each, separated by 5 nights in which participants will use their personal APAP device. The modified APAP device is switchable between two therapy modes: a) proactive therapy, and b) conventional APAP therapy. Treatment for the 2 periods will be randomly assigned, with one period as the test period where the proactive therapy is used every night for 9 consecutive nights, and the other as the control period where their conventional APAP therapy (i.e., the participant's regular therapy but on the modified device) is used every night for 9 consecutive nights. Participants will be blinded to the therapy they are receiving during the test and control period. Data will be collected by the modified PAP device and at-home sleep apnea test ring.

Conditions

• Obstructive Sleep Apnea
• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Proactive Therapy	Uses AI to make predictions and preventions of future apneic events.

Timeline

• Start date: 2024-03-25
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2023-11-22
• Last updated: 2024-03-07