NCT03971721

Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home

A Feasibility Study to Determine the Effects of a Novel Mattress Support for Treatment of Positional Obstructive Sleep Apnea at Home

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a preliminary single-arm study. The study will last up to 4 weeks including the screening period. Subjects will sleep using the mattress support at home for two consecutive weeks. Outcome measures will include: AHI derived from HSAT (primary outcome), oxygen desaturation index (ODI), Epworth Sleepiness Scale (ESS) score, Functional Outcomes of Sleep Questionnaire (FOSQ), Visual Analog Scale (VAS) and questionnaire assessments of sleep quality, and actigraphic sleep measures. Subjects will also keep a sleep diary every night for the duration of the study. Subjects will be asked about their bed partners' report on snoring and witnessed apneas.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DEVICE	Wave 4.3	The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-06-03
• Last updated: 2021-03-16
• Results posted: 2021-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study