NCT05268471

Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea

Cost-effectiveness Analysis and Conditional Response to the Effect of Active Postural Devices in Postural Obstructive Sleep Apnea. Pávlov Project.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are: * To assess the effectiveness and cost-effectiveness of a vibrating positional device (NightBalance, Philips) in the treatment of positional obstructive sleep apnea compared to conventional CPAP treatment. * To investigate whether a positional device (NightBalance, Philips) avoids supine position after a period of use of the device without actively using the device for a subsequent period of time.

Detailed description

Non-inferiority clinical trial open to patients and investigators, multicenter, randomized and controlled to treatment with positional device (PD) and CPAP to evaluate the effectiveness of treatment of positional obstructive sleep apnea with a PD (NightBalance, Philips) compared to CPAP after 6 months of continuous treatment (first phase) and the permanence of such efficacy after subsequent discontinuation of treatment (second phase). An initial respiratory polygraphy will be performed in all patients and the sleep study will be repeated at 6 months with PD and CPAP. After its withdrawal, in those patients who respond, the respiratory polygraphy will be repeated at one week and one month.

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DEVICE	Positional device (PD)	OSA treatment with PD for 6 months
DEVICE	Continuos Positive Airway Pressure (CPAP)	OSA treatment with CPAP for 6 months

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-06-30
• Completion: 2024-12-01
• First posted: 2022-03-07
• Last updated: 2022-08-24

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study