The Ohio State University Martha Morehouse Medical Pavilion 2050 Kenny Rd;Ste 2600
Columbus, Ohio, 43221, United States
NCT Number: NCT02250417
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 or soft palate. In a significant number of individuals with OSA, the severity of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine (back) position and lowers in the lateral (side) position. This is called positional OSA.
The primary objective of this study is to determine whether sleeping with a novel sleep surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those with positional OSA.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Columbus, Ohio, 43221, United States
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. A secondary aim is to determine the effects of the sleep surface on subjective and objective measures of sleep in patients with positional OSA.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
We will recruit subjects who are:
Exclusion criteria
The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.
Time frame: measured during each of the two sleep study sessions (Study Visits 2 and 3)
AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep.
These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea.
This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.
Time frame: measured during each of the two sleep study sessions (Study Visits 2 and 3)
Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3.
Time frame: measured during each of the two sleep study sessions (Study Visits 2 and 3)
Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3. Sleep efficiency is defined as the total sleep time divided by the total recording time X100.
Ohio State University
Other
Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea.
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