A Multi-center, Prospective, Randomized Crossover Study with the NightBalance Lunoa SPT Compared to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)

Philips0 个研究点目标入组 150 人开始时间: 2018年4月27日最近更新: 2024年5月21日

试验速览

暂无简介。

•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.

•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

发起方