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

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ClinicalTrials.gov Identifier: NCT03061071
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
NightBalance

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Device: NightBalance Sleep Position Trainer (SPT) Device: Automated Adjusting Positive Airway Pressure (APAP) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 6 week crossover study, randomized to order of treatment
Masking: Single (Outcomes Assessor)
Masking Description: The technician scoring the polysomnograms will be unaware of previous PSG results from the patient to the best of their ability (ie: will not look back in their records for the purpose of reviewing their previous PSGs prior to scoring).
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : July 12, 2018
Actual Study Completion Date : July 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. Apnea-Hypopnea Index (AHI, events/hr) [ Time Frame: 6 week ]
    Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)


Secondary Outcome Measures :
  1. Epworth Sleepiness Scale (ESS) [ Time Frame: 6 week ]
    SPT vs. APAP

  2. Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 6 week ]
    SPT vs. APAP

  3. SF-36 [ Time Frame: 6 week ]
    SPT vs. APAP

  4. Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS) [ Time Frame: 6 week ]
    SPT vs. APAP

  5. Oxygen Desaturation Index (3%) [ Time Frame: 6 week ]
    SPT vs. APAP

  6. Total Sleep Time (minutes) [ Time Frame: 6 week ]
    SPT vs. APAP (measured by in lab polysomnography)

  7. Sleep Onset Latency (minutes) [ Time Frame: 6 week ]
    SPT vs. APAP (measured by in lab polysomnography)

  8. Sleep Efficiency (%) [ Time Frame: 6 week ]
    SPT vs. APAP (measured by in lab polysomnography)

  9. Arousal Index [ Time Frame: 6 week ]
    SPT vs. APAP (measured by in lab polysomnography)

  10. Sleep Stages (%) [ Time Frame: 6 week ]
    SPT vs. APAP (measured by in lab polysomnography)

  11. Sleep Position (%) [ Time Frame: 6 week ]
    SPT vs. APAP (measured by in lab polysomnography)

  12. 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.)

  13. Adverse Events [ Time Frame: 6 weeks ]
    SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061071


Locations
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United States, Alabama
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
United States, Arizona
Sleep Med Inc., AZ
Glendale, Arizona, United States, 85306
United States, Florida
Sleep Disorders at Magnolia Park
Gainesville, Florida, United States, 32606
United States, Kentucky
Kentucky Research Group
Louisville, Kentucky, United States, 40218
United States, Maryland
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States, 20815
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
St. Luke's Sleep Medicine and Research Center
Chesterfield, Missouri, United States, 63017
Clayton Sleep Institute
Maplewood, Missouri, United States, 63143
United States, North Carolina
Med One Sleep
Fayetteville, North Carolina, United States, 28304
United States, Pennsylvania
Pearl Clinical Research
Paoli, Pennsylvania, United States, 19301
United States, South Carolina
SleepMed of South Carolina
Columbia, South Carolina, United States, 29201
Sponsors and Collaborators
NightBalance
Investigators
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Principal Investigator: Richard B Berry, MD UF Health Sleep Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NightBalance
ClinicalTrials.gov Identifier: NCT03061071    
Other Study ID Numbers: US-2017-001
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NightBalance:
Positional Sleep Apnea
Positional Obstructive Sleep Apnea
POSA
 OSA
Obstructive Sleep Apnea
Sleep Apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases