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

August 20, 2018 updated by: NightBalance

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Sleep Disorders Center of Alabama
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Sleep Med Inc., AZ
    • Florida
      • Gainesville, Florida, United States, 32606
        • Sleep Disorders at Magnolia Park
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Kentucky Research Group
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Center For Sleep and Wake Disorders
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Luke's Sleep Medicine and Research Center
      • Maplewood, Missouri, United States, 63143
        • Clayton Sleep Institute
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Med One Sleep
    • Pennsylvania
      • Paoli, Pennsylvania, United States, 19301
        • Pearl Clinical Research
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Sleepmed of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  11. Shoulder, neck, or back complaints that restrict sleeping position.
  12. Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Randomized to SPT First: APAP Second
Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment.
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.
Experimental: Randomized to APAP First: SPT Second
Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence (minutes of device use per night)
Time Frame: 6 week
Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)
6 week
Apnea-Hypopnea Index (AHI, events/hr)
Time Frame: 6 week
Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)
6 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale (ESS)
Time Frame: 6 week
SPT vs. APAP
6 week
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time Frame: 6 week
SPT vs. APAP
6 week
SF-36
Time Frame: 6 week
SPT vs. APAP
6 week
Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)
Time Frame: 6 week
SPT vs. APAP
6 week
Oxygen Desaturation Index (3%)
Time Frame: 6 week
SPT vs. APAP
6 week
Total Sleep Time (minutes)
Time Frame: 6 week
SPT vs. APAP (measured by in lab polysomnography)
6 week
Sleep Onset Latency (minutes)
Time Frame: 6 week
SPT vs. APAP (measured by in lab polysomnography)
6 week
Sleep Efficiency (%)
Time Frame: 6 week
SPT vs. APAP (measured by in lab polysomnography)
6 week
Arousal Index
Time Frame: 6 week
SPT vs. APAP (measured by in lab polysomnography)
6 week
Sleep Stages (%)
Time Frame: 6 week
SPT vs. APAP (measured by in lab polysomnography)
6 week
Sleep Position (%)
Time Frame: 6 week
SPT vs. APAP (measured by in lab polysomnography)
6 week
Mean Disease Alleviation (MDA) (%)
Time Frame: 6 weeks
SPT vs. APAP (MDA (%) is calculated by the product of the objective adherence (from SPT and APAP download), adjusted for total sleep time (X-axis), combined with therapeutic efficacy (AHI from the respective treatment night, Y-axis), divided by 100.)
6 weeks
Adverse Events
Time Frame: 6 weeks
SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NightBalance

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard B Berry, MD, UF Health Sleep Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • US-2017-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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