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The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea

NCT03061071 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2018-08-21

No results posted yet for this study

Summary

This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).

Conditions

  • Sleep Apnea Syndromes

Interventions

DEVICE

NightBalance Sleep Position Trainer (SPT)

Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.

DEVICE

Automated Adjusting Positive Airway Pressure (APAP)

Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.

Sponsors & Collaborators

  • NightBalance

    lead INDUSTRY

Principal Investigators

  • Richard B Berry, MD · UF Health Sleep Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-07-12
Completion
2018-07-12
FDA Device
Yes

Countries

  • United States

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 NCT03061071 on ClinicalTrials.gov