Back to resultsThe POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea Syndromes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NightBalance Sleep Position Trainer (SPT)
Automated Adjusting Positive Airway Pressure (APAP)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Positional Sleep Apnea, Positional Obstructive Sleep Apnea, POSA, OSA, Obstructive Sleep Apnea, Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Subject is between the ages of 20 and 80.
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%
- Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
Exclusion Criteria:
- 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.
- A female of child-bearing potential that is pregnant or intends to become pregnant.
- 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).
- Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants.
- Oxygen use.
- The presence of any other sleep disorder (central sleep apnea (CSA >5), periodic limb movement disorder (PLMAI >15), clinical diagnosis of insomnia or narcolepsy).
- Excessive alcohol consumption (>21 drinks/week).
- The use of any illegal drug(s).
- Night or rotating shift work.
- Severe claustrophobia.
- Shoulder, neck, or back complaints that restrict sleeping position.
- Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.
Sites / Locations
- Sleep Disorders Center of Alabama
- Sleep Med Inc., AZ
- Sleep Disorders at Magnolia Park
- Kentucky Research Group
- Center for Sleep and Wake Disorders
- University of Michigan
- St. Luke's Sleep Medicine and Research Center
- Clayton Sleep Institute
- Med One Sleep
- Pearl Clinical Research
- SleepMed of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Randomized to SPT First: APAP Second
Randomized to APAP First: SPT Second
Arm Description
Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment.
Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment.
Outcomes
Primary Outcome Measures
Adherence (minutes of device use per night)
Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)
Apnea-Hypopnea Index (AHI, events/hr)
Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)
Secondary Outcome Measures
Epworth Sleepiness Scale (ESS)
SPT vs. APAP
Functional Outcomes of Sleep Questionnaire (FOSQ)
SPT vs. APAP
SF-36
SPT vs. APAP
Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)
SPT vs. APAP
Oxygen Desaturation Index (3%)
SPT vs. APAP
Total Sleep Time (minutes)
SPT vs. APAP (measured by in lab polysomnography)
Sleep Onset Latency (minutes)
SPT vs. APAP (measured by in lab polysomnography)
Sleep Efficiency (%)
SPT vs. APAP (measured by in lab polysomnography)
Arousal Index
SPT vs. APAP (measured by in lab polysomnography)
Sleep Stages (%)
SPT vs. APAP (measured by in lab polysomnography)
Sleep Position (%)
SPT vs. APAP (measured by in lab polysomnography)
Mean Disease Alleviation (MDA) (%)
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.)
Adverse Events
SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03061071
Brief Title
The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 12, 2018 (Actual)
Study Completion Date
July 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NightBalance
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
Positional Sleep Apnea, Positional Obstructive Sleep Apnea, POSA, OSA, Obstructive Sleep Apnea, Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
6 week crossover study, randomized to order of treatment
Masking
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).
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Randomized to SPT First: APAP Second
Arm Type
Experimental
Arm Description
Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment.
Arm Title
Randomized to APAP First: SPT Second
Arm Type
Experimental
Arm Description
Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment.
Intervention Type
Device
Intervention Name(s)
NightBalance Sleep Position Trainer (SPT)
Intervention Description
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.
Intervention Type
Device
Intervention Name(s)
Automated Adjusting Positive Airway Pressure (APAP)
Intervention Description
Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.
Primary Outcome Measure Information:
Title
Adherence (minutes of device use per night)
Description
Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)
Time Frame
6 week
Title
Apnea-Hypopnea Index (AHI, events/hr)
Description
Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Epworth Sleepiness Scale (ESS)
Description
SPT vs. APAP
Time Frame
6 week
Title
Functional Outcomes of Sleep Questionnaire (FOSQ)
Description
SPT vs. APAP
Time Frame
6 week
Title
SF-36
Description
SPT vs. APAP
Time Frame
6 week
Title
Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)
Description
SPT vs. APAP
Time Frame
6 week
Title
Oxygen Desaturation Index (3%)
Description
SPT vs. APAP
Time Frame
6 week
Title
Total Sleep Time (minutes)
Description
SPT vs. APAP (measured by in lab polysomnography)
Time Frame
6 week
Title
Sleep Onset Latency (minutes)
Description
SPT vs. APAP (measured by in lab polysomnography)
Time Frame
6 week
Title
Sleep Efficiency (%)
Description
SPT vs. APAP (measured by in lab polysomnography)
Time Frame
6 week
Title
Arousal Index
Description
SPT vs. APAP (measured by in lab polysomnography)
Time Frame
6 week
Title
Sleep Stages (%)
Description
SPT vs. APAP (measured by in lab polysomnography)
Time Frame
6 week
Title
Sleep Position (%)
Description
SPT vs. APAP (measured by in lab polysomnography)
Time Frame
6 week
Title
Mean Disease Alleviation (MDA) (%)
Description
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.)
Time Frame
6 weeks
Title
Adverse Events
Description
SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is between the ages of 20 and 80.
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%
Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
Exclusion Criteria:
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.
A female of child-bearing potential that is pregnant or intends to become pregnant.
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).
Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants.
Oxygen use.
The presence of any other sleep disorder (central sleep apnea (CSA >5), periodic limb movement disorder (PLMAI >15), clinical diagnosis of insomnia or narcolepsy).
Excessive alcohol consumption (>21 drinks/week).
The use of any illegal drug(s).
Night or rotating shift work.
Severe claustrophobia.
Shoulder, neck, or back complaints that restrict sleeping position.
Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Berry, MD
Organizational Affiliation
UF Health Sleep Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Sleep Med Inc., AZ
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Sleep Disorders at Magnolia Park
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
Center for Sleep and Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
St. Luke's Sleep Medicine and Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Clayton Sleep Institute
City
Maplewood
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Med One Sleep
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Pearl Clinical Research
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
SleepMed of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31383231
Citation
Berry RB, Uhles ML, Abaluck BK, Winslow DH, Schweitzer PK, Gaskins RA Jr, Doekel RC Jr, Emsellem HA. NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Jul 15;15(7):947-956. doi: 10.5664/jcsm.7868.
Results Reference
derived
Learn more about this trial
The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea
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