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

Sleep Apnea Syndromes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061071
• Other study ID #: US-2017-001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: July 12, 2018

Study information

• Verified date: August 2018
• Source: NightBalance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• NightBalance Sleep Position Trainer (SPT)
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.
• Automated Adjusting Positive Airway Pressure (APAP)
Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	St. Luke's Sleep Medicine and Research Center	Chesterfield	Missouri
United States	Center for Sleep and Wake Disorders	Chevy Chase	Maryland
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Med One Sleep	Fayetteville	North Carolina
United States	Sleep Disorders at Magnolia Park	Gainesville	Florida
United States	Sleep Med Inc., AZ	Glendale	Arizona
United States	Kentucky Research Group	Louisville	Kentucky
United States	Clayton Sleep Institute	Maplewood	Missouri
United States	Pearl Clinical Research	Paoli	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
NightBalance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Apnea-Hypopnea Index (AHI, events/hr)	Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)	6 week
Secondary	Epworth Sleepiness Scale (ESS)	SPT vs. APAP	6 week
Secondary	Functional Outcomes of Sleep Questionnaire (FOSQ)	SPT vs. APAP	6 week
Secondary	SF-36	SPT vs. APAP	6 week
Secondary	Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)	SPT vs. APAP	6 week
Secondary	Oxygen Desaturation Index (3%)	SPT vs. APAP	6 week
Secondary	Total Sleep Time (minutes)	SPT vs. APAP (measured by in lab polysomnography)	6 week
Secondary	Sleep Onset Latency (minutes)	SPT vs. APAP (measured by in lab polysomnography)	6 week
Secondary	Sleep Efficiency (%)	SPT vs. APAP (measured by in lab polysomnography)	6 week
Secondary	Arousal Index	SPT vs. APAP (measured by in lab polysomnography)	6 week
Secondary	Sleep Stages (%)	SPT vs. APAP (measured by in lab polysomnography)	6 week
Secondary	Sleep Position (%)	SPT vs. APAP (measured by in lab polysomnography)	6 week
Secondary	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
Secondary	Adverse Events	SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized.	6 weeks