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)

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: Completed
• Conditions: Sleep Apnea Syndromes
• Intervention / Treatment: Device: NightBalance Sleep Position Trainer (SPT); Device: Automated Adjusting Positive Airway Pressure (APAP)

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: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence (minutes of device use per night)	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)	Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)	6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Scale (ESS)	SPT vs. APAP	6 week
Functional Outcomes of Sleep Questionnaire (FOSQ)	SPT vs. APAP	6 week
SF-36	SPT vs. APAP	6 week
Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)	SPT vs. APAP	6 week
Oxygen Desaturation Index (3%)	SPT vs. APAP	6 week
Total Sleep Time (minutes)	SPT vs. APAP (measured by in lab polysomnography)	6 week
Sleep Onset Latency (minutes)	SPT vs. APAP (measured by in lab polysomnography)	6 week
Sleep Efficiency (%)	SPT vs. APAP (measured by in lab polysomnography)	6 week
Arousal Index	SPT vs. APAP (measured by in lab polysomnography)	6 week
Sleep Stages (%)	SPT vs. APAP (measured by in lab polysomnography)	6 week
Sleep Position (%)	SPT vs. APAP (measured by in lab polysomnography)	6 week
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.)	6 weeks
Adverse Events	SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized.	6 weeks

Collaborators and Investigators

• Sponsor: NightBalance
• Investigators: Principal Investigator: Richard B Berry, MD, UF Health Sleep Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): July 12, 2018
• Study Completion (Actual): July 12, 2018

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Positional Sleep Apnea; Positional Obstructive Sleep Apnea; POSA; OSA; Obstructive Sleep Apnea; Sleep Apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID 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