Investigation of the efficacy of positional therapy provided by the SleepAssist device in patients suffering from Positional Obstructive Sleep Apnea (POSA)

The Sleep Company B.V.0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•Main inclusion criteria•Subject is =18 years of age.
•Treatment naïve, i.e. no prior or current (P)OSA treatment
•a BMI (Body Mass Index) < 35
•Diagnosis of POSA through PSG analysis that was carried out within 8 weeks of enrolment, meeting all the following criteria:
•oAHI (supine position) > 2 times higher than AHI (non-supine position)
•oAHI (lateral) =10 per hr
•oAHI =5 per hr and <30 per hr (mild to moderate severity)
•o % Supine sleeping time between 10 and 90% of the Total Sleeping Time (TST)
•Understands the study protocol and is willing and able to comply with study requirements and sign informed consent.

•Main exclusion criteria•A female of child-bearing potential that is pregnant, as confirmed by urine pregnancy test, or intends to become pregnant, or is breast-feeding
•Chronic Obstructive Pulmonary Disease, COPD Gold Class > 2
•Cardiac failure, NYHA class > II
•Chronic Renal Failure, G2 class > 2
•Uncontrolled Diabetes Mellitus type I or II
•Joint, muscle or bone abnormalities due to orthopaedic conditions or rheumatic diseases that impair the sleeping position of the patient
•Hemoglobinopathies (e.g. sickle cell disease)
•Active oncological disease or active/ongoing treatment for oncological disease
•Use of prescription opioids
•Oxygen use
•The presence of any other sleep disorder (central sleep apnoea, periodic limb movement disorder, clinical diagnosis of insomnia or narcolepsy)
•Any other major congenital or chronic disease which is not well controlled on the day of enrolment
•Major surgical procedures, which might affect sleeping or sleeping position, within 4 weeks of enrolment, or planned within the study period
•Excessive alcohol consumption (>4 drinks/day and/or >21 drinks/week)
•The use of any illegal drug(s), per subject report
•Night or rotating shift work at screening or planned during the study period
•Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position
•Subject sleeps on a waterbed

发起方

The Sleep Company B.V.