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

Not Applicable

Completed

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

• Registration Number: NCT03061071
• Lead Sponsor: NightBalance

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.

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Study Start: 2017-03-01
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Randomized to SPT First: APAP Second	NightBalance Sleep Position Trainer (SPT)	Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment.
Randomized to APAP First: SPT Second	Automated Adjusting Positive Airway Pressure (APAP)	Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment.
Randomized to SPT First: APAP Second	Automated Adjusting Positive Airway Pressure (APAP)	Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment.
Randomized to APAP First: SPT Second	NightBalance Sleep Position Trainer (SPT)	Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment.

Primary Outcome Measures

Name	Time	Method
Adherence (minutes of device use per night)	6 week	Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)
Apnea-Hypopnea Index (AHI, events/hr)	6 week	Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Kentucky Research Group; 🇺🇸 Louisville, Kentucky, United States

Center for Sleep and Wake Disorders; 🇺🇸 Chevy Chase, Maryland, United States

Sleep Med Inc., AZ; 🇺🇸 Glendale, Arizona, United States

Sleep Disorders at Magnolia Park; 🇺🇸 Gainesville, Florida, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

St. Luke's Sleep Medicine and Research Center; 🇺🇸 Chesterfield, Missouri, United States

Sleep Disorders Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

SleepMed of South Carolina; 🇺🇸 Columbia, South Carolina, United States

Clayton Sleep Institute; 🇺🇸 Maplewood, Missouri, United States

Med One Sleep; 🇺🇸 Fayetteville, North Carolina, United States

Pearl Clinical Research; 🇺🇸 Paoli, Pennsylvania, United States