Clinical trial NCT03061071: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Keywords: Positional Sleep Apnea
Positional Obstructive Sleep Apnea
POSA
OSA
Obstructive Sleep Apnea
Sleep Apnea
Lead sponsor: NightBalance
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 117
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 6 week crossover study, randomized to order of treatment
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Adherence (minutes of device use per night)
timeFrame: 6 week
measure: Apnea-Hypopnea Index (AHI, events/hr)
timeFrame: 6 week
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 6 week
measure: Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 6 week
measure: SF-36
timeFrame: 6 week
measure: Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)
timeFrame: 6 week
measure: Oxygen Desaturation Index (3%)
timeFrame: 6 week
measure: Total Sleep Time (minutes)
timeFrame: 6 week
measure: Sleep Onset Latency (minutes)
timeFrame: 6 week
measure: Sleep Efficiency (%)
timeFrame: 6 week
measure: Arousal Index
timeFrame: 6 week
measure: Sleep Stages (%)
timeFrame: 6 week
measure: Sleep Position (%)
timeFrame: 6 week
measure: Mean Disease Alleviation (MDA) (%)
timeFrame: 6 weeks
measure: Adverse Events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Glendale
country: United States
facility: Sleep Med Inc., AZ
state: Arizona
city: Gainesville
country: United States
facility: Sleep Disorders at Magnolia Park
state: Florida
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Chevy Chase
country: United States
facility: Center for Sleep and Wake Disorders
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: St. Luke's Sleep Medicine and Research Center
state: Missouri
city: Maplewood
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Fayetteville
country: United States
facility: Med One Sleep
state: North Carolina
city: Paoli
country: United States
facility: Pearl Clinical Research
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
Study officials:
affiliation: UF Health Sleep Center
name: Richard B Berry, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.