Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home

Stopped early · Not applicable

Conditions studied: Sleep Apnea, Obstructive

In brief

1. Determine the effects of a mattress support (Wave 4.3) that promotes the avoidance of supine airway position at home on the apnea-hypopnea index (AHI) in patients with positional obstructive sleep apnea (OSA). 2. Determine the effects of Wave 4.3 on subjective measures of sleepiness and daytime function in patients with positional OSA. 3. Determine the effects of Wave 4.3 on subjective measures of sleep quality in patients with positional OSA.

Key facts

Study ID

NCT03971721

Run by

Ohio State University

People needed

3

Starts

2019-07-01

Expected to finish

2020-01-01

Last updated by the study team

2021-03-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 18-75 years of age
• Willing and able to give informed consent
• Able to speak and understand English
• Previous sleep study prior to enrollment done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care:
• overall AHI 5-40 events/hr.
• at least 10% time spent in the supine and 10% time in the non-supine positions.
• APOC I and APOC II
• central respiratory events < 50% of the total number of apneas and hypopneas
• Using at least a queen-sized mattress when sleeping at home
• Patients who meet the above criteria who have been prescribed CPAP or dental device but are non-adherent to treatment will be enrolled in the study. CPAP non-adherence will be defined as average nightly use < 4hrs/night based on a download of the CPAP machine, or self- acknowledged discontinuation or non-regular of CPAP use.

You may not qualify if…

• • Incapable of giving informed consent
• Under the age of 18
• Active titration of medication
• Pregnancy, lactation (will be screened with urine pregnancy test)
• Self-reported Substance abuse (current)
• Excessive alcohol consumption
• Excessive alcohol use is defined as:
• More than 3 glasses of wine a day
• More than 3 beers a day
• More than 60 mL of hard liquor a day
• Use of home oxygen
• Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score > 16 or a prior history of falling asleep while driving
• Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD).
• Unstable medical problem such as uncontrolled hypertension.
• Body Mass Index (BMI) >45 kg/m2
• Any other clinically significant condition that, in the opinion of the investigators, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.

Where it is running

• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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