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

NightBalance

Status: Completed

Conditions: Sleep Apnea Syndromes

Treatments: Device: NightBalance Sleep Position Trainer (SPT); Device: Automated Adjusting Positive Airway Pressure (APAP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03061071

US-2017-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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117 participants in 2 patient groups

Randomized to SPT First: APAP Second

Experimental group

Description:

Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment.

Treatment:

Device: NightBalance Sleep Position Trainer (SPT)

Device: Automated Adjusting Positive Airway Pressure (APAP)

Randomized to APAP First: SPT Second

Experimental group

Description:

Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment.

Treatment:

Device: NightBalance Sleep Position Trainer (SPT)

Device: Automated Adjusting Positive Airway Pressure (APAP)