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The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea | Clinical Trials | Clareo Health

COMPLETEDNA

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

A Prospective, Randomized, Crossover Study of the NightBalance Sleep Position Trainer (SPT) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)

NCT03061071•NightBalance

View on ClinicalTrials.gov

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).

Detailed Description

This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of POSA. The Primary Objective of the study is to demonstrate non-inferiority of treatment with the SPT as compared to APAP.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is between the ages of 20 and 80.
•2. Diagnosis of POSA meeting all the following criteria per in-lab control PSG (performed within 3 months of screening):
•* Total AHI \>15, or AHI \>10 and \<15 with ESS \>10
•* Supine AHI at least twice the non-supine AHI
•* Non-supine AHI \<10 (\<5 in mild patients)
•* Supine time \>40% and \<60%
•3. Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.

Exclusion Criteria

•1. Prior surgery to treat OSA (such as UPPP), or prior or current therapy or treatment for OSA, with the exception of PAP being used for split night PSG only.
•2. A female of child-bearing potential that is pregnant or intends to become pregnant.
•3. Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, or at the discretion of the site Principal Investigator (PI).
•4. Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants.
•5. Oxygen use.
•6. The presence of any other sleep disorder (central sleep apnea (CSA \>5), periodic limb movement disorder (PLMAI \>15), clinical diagnosis of insomnia or narcolepsy).
•7. Excessive alcohol consumption (\>21 drinks/week).
•8. The use of any illegal drug(s).
•9. Night or rotating shift work.
•10. Severe claustrophobia.
+2 more criteria

Locations (11)

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Sleep Med Inc., AZ

Glendale, Arizona, United States

Sleep Disorders at Magnolia Park

Gainesville, Florida, United States

Kentucky Research Group

Louisville, Kentucky, United States

Center for Sleep and Wake Disorders

Chevy Chase, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

St. Luke's Sleep Medicine and Research Center

Chesterfield, Missouri, United States

Clayton Sleep Institute

Maplewood, Missouri, United States

Med One Sleep

Fayetteville, North Carolina, United States

Pearl Clinical Research

Paoli, Pennsylvania, United States

Key Dates

Start Date

March 1, 2017

Primary Completion Date

July 12, 2018

Completion Date

July 12, 2018

Last Updated

August 21, 2018

Enrollment

117

ACTUAL participants

Conditions

Sleep Apnea Syndromes

Interventions

NightBalance Sleep Position Trainer (SPT)

DEVICE

Automated Adjusting Positive Airway Pressure (APAP)

DEVICE

Apnea, Stroke and Incident Cardiovascular Events

NCT04399200

StrokeSleep-disordered Breathing+4 more

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ENROLLING_BY_INVITATIONNA

Fascial Mobilization Along the Vagus Nerve and Its Effects on Acute Physiological Parameters in Obstructive Sleep Apnea

NCT07169058

Obstructive Sleep Apnea Syndromes

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Apnea, Stroke and Incident Cardiovascular Events

Fascial Mobilization Along the Vagus Nerve and Its Effects on Acute Physiological Parameters in Obstructive Sleep Apnea

Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

Janus Feasibility Study

Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy

Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea