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

NCT05268471 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2022-08-24

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea of Adult

Interventions

DEVICE

Positional device (PD)

OSA treatment with PD for 6 months

DEVICE

Continuos Positive Airway Pressure (CPAP)

OSA treatment with CPAP for 6 months

Sponsors & Collaborators

  • Philips Healthcare

    collaborator INDUSTRY

  • Hospital Universitario Ramon y Cajal

    lead OTHER

Principal Investigators

  • Irene Cano-Pumarega, MD, PhD · Hospital Universitario Ramón y Cajal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-06-30
Completion
2024-12-01
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05268471 on ClinicalTrials.gov