Comparison of the NightBalance Lunoa to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)

Not Applicable

Completed

• Conditions: Sleep apnea; Respiratory; Positional obstructive sleep apnea

• Registration Number: ISRCTN16170657
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-27
• Study Completion: 2021-01-31
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subject is adult
2. Either:
2.1. Treatment naïve, or
2.2. PAP non-complier (defined as current AAP user with <3 hours per night in the last 3 months per compliance download), and willing to use the APAP device per protocol
3. Diagnosis of POSA meeting all the following criteria per control PSG within 6 months of screening:
3.1. AHI of >15 during PSG with symptoms of sleepiness per Investigator discretion, or AHI of >15 during respiratory polygraphy with comorbidities (e.g. atrial fibrillation, resistant hypertension, etc.)
3.2. Supine AHI at least twice the lateral AHI
3.3. Lateral AHI <10
3.4. Supine time >30% and <70%
4. Understands the study protocol and is willing and able to comply with study requirements and sign informed consent. APAP non-compliant subjects must be willing to use their APAP device per protocol.

Exclusion Criteria

1. Prior or current therapy or treatment for OSA (for Treatment naïve group); Greater than an average of 3 hours per night of APAP use (in the APAP non-complier group)
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 that at the discretion of the site Principal Investigator (PI) might affect the patient’s participation in the study or generalization of treatment results
4. Taking medication that at the discretion of the site Principal Investigator (PI) might affect the patient’s participation in the study or generalization of treatment results
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), per subject report
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: Not specified