Status:
COMPLETED
Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Hill-Rom
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI is the number of times per hour of sleep that the airway temporarily collapses at the level of the tongue o...
Detailed Description
The primary objective of this study is to determine whether sleeping with the novel device (Wave sleep surface) reduces the AHI in those with supine position-related OSA, also known as positional OSA....
Eligibility Criteria
Inclusion
- We will recruit subjects who are:
- 18 years of age and above
- Willing and able to give informed consent
- Prior sleep study done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care and performed no more than 12 months prior to enrollment that meets the following:
- overall AHI 5-30 events/hr
- at least 20 minutes of recorded sleep in the supine and nonsupine postures
- positional OSA defined as \> 50% reduction in the AHI between the supine and nonsupine postures and AHI \< 5hr in the nonsupine position
- central apneas \< 50% of the total number of apneas and hypopneas
- Patients who meet the above criteria who have been prescribed CPAP therapy but are non-compliant will be enrolled in the study. CPAP noncompliance will be defined as average nightly use \< 4hrs/night based on a download of the CPAP machine, or self- acknowledged discontinuation of CPAP use.
Exclusion
- Incapable of giving informed consent
- Under the age of 18
- Known inability to sleep in the lateral position
- Active titration of medication
- 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
- Room air oxyhemoglobin saturation \< 88%
- Use of home oxygen
- Compliant with OSA therapy
- Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score \> 16 or a prior history of falling asleep while driving
- Unstable medical problem such as uncontrolled hypertension.
- Body Mass Index (BMI) \> 45 kg/m2
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02250417
Start Date
August 1 2014
End Date
August 1 2015
Last Update
August 8 2018
Active Locations (1)
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1
The Ohio State University Martha Morehouse Medical Pavilion 2050 Kenny Rd;Ste 2600
Columbus, Ohio, United States, 43221