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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Sleep Apnea Syndromes

Intervention / Treatment
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* Device: NightBalance Sleep Position Trainer (SPT)
* Device: Automated Adjusting Positive Airway Pressure (APAP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 6 week crossover study, randomized to order of treatment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized to SPT First: APAP Second<br>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)<br>* Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.<br>Device: Automated Adjusting Positive Airway Pressure (APAP)<br>* Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.<br>|
| Experimental: Randomized to APAP First: SPT Second<br>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)<br>* Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.<br>Device: Automated Adjusting Positive Airway Pressure (APAP)<br>* Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea, Positional Sleep Apnea, Positional Obstructive Sleep Apnea, POSA, OSA, Obstructive Sleep Apnea