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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
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.
The Ohio State University
Columbus, Ohio, United States
Apnea-Hypopnea Index Difference Between Two Nights
Apnea-Hypopnea Index derived from Home Sleep Test. The apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep between two nights. AHI\<5 is indicative of no sleep apnea, AHI 5-15 is indicative of mild sleep apnea, AHI 15-30 is indicative of moderate sleep apnea, AHI\>30 is indicative of severe sleep apnea. The minimum AHI is 0, and there is no maximum. A higher score means a worse outcome. Subscales are not used to compute the value. The difference was calculated based on the value at night 1 minus the value at night 2 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Time frame: 2 nights
Oxygen Desaturation Index Difference Between Two Nights
Oxygen Desaturation Index calculated based on the average between two nights measured. Desaturation episodes are generally described as a decrease in the mean oxygen saturation of ≥4% (over the last 120 seconds) that lasts for at least 10 seconds. ODI values can range from 0 to greater than 30. A higher score means a worse outcome. Subscales are not used to compute the value. The difference was calculated based on the value at night 1 minus the value at night 2 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Time frame: 2 nights
Epworth Sleepiness Score
A subjective measure of sleepiness on average based on the total score. The score ranges from a minimum of 0 to a maximum of 24. A higher score means a worse outcome. Subscales are not used to compute the value. The difference was calculated based on the value at visit 1 minus the value at visit 4 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Time frame: Completed at Visit 1 and Visit 4 (~5 minutes)
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Functional Outcomes of Sleep Questionnaire Score
A subjective measure of sleepiness on daytime function with an average of the total score. The score ranges from a minimum of 0 to a maximum of 20. A higher score means a better outcome. Subscales are not used to compute the value. The difference was calculated based on the value at visit 2 minus the value at visit 4 (converted to a positive value if the difference created a negative value). The difference was calculated based on the value at visit 2 minus the value at visit 4 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Time frame: Completed at Visit 2 and Visit 4 (~5 minutes)
Visual Analog Scale Score
A subjective measure of sleepiness with the average of the total score. The score ranges from a minimum of 0 to a maximum of 100. A higher score means a better outcome. Subscales are not used to compute the value. The difference was calculated based on the value at visit 2 minus the value at visit 4 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Time frame: Completed at Visit 2 and Visit 4 (~5 minutes)