NCT03971721

Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home

Terminated NA Results posted Last updated 16 March 2021

What this trial tests

NA trial testing Wave 4.3 in Sleep Apnea, Obstructive in 3 participants. Terminated before completion.

Timeline

1 July 2019

Primary endpoint
1 January 2020

1 January 2020

Quick facts

Lead sponsor	Ohio State University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	1 July 2019
Primary completion	1 January 2020
Estimated completion	1 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Wave 4.3

Conditions studied

• Sleep Apnea, Obstructive — all drugs for Sleep Apnea, Obstructive →

Sponsor

Ohio State University

Who can join

Adults 18 to 75, any sex, with Sleep Apnea, Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Apnea-Hypopnea Index Difference Between Two Nights Primary · 2 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 pos

Group	Value	95% CI
Wave Mattress Support	2.03	± 4.20

Oxygen Desaturation Index Difference Between Two Nights Secondary · 2 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 bas

Group	Value	95% CI
Wave Mattress Support	1.33	± 4.25

Epworth Sleepiness Score Secondary · Completed at Visit 1 and Visit 4 (~5 minutes)

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.

Group	Value	95% CI
Wave Mattress Support	6.67	± 3.21

Functional Outcomes of Sleep Questionnaire Score Secondary · Completed at Visit 2 and Visit 4 (~5 minutes)

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 th

Group	Value	95% CI
Wave Mattress Support	2.00	± 1.41

Visual Analog Scale Score Secondary · Completed at Visit 2 and Visit 4 (~5 minutes)

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.

Group	Value	95% CI
Wave Mattress Support	34	± 0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.