NCT02250417

Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea

Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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. A secondary aim is to determine the effects of the sleep surface on subjective and objective measures of sleep in patients with positional OSA.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
OTHER	Wave sleep surface	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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-04-01
• Completion: 2015-08-01
• First posted: 2014-09-26
• Last updated: 2018-08-08
• Results posted: 2018-08-08

Locations

1 site across 1 country: United States