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Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home

Primary Purpose

Sleep Apnea, Obstructive

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wave 4.3
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Positional therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 18-75 years of age

    • Willing and able to give informed consent
    • Able to speak and understand English

    • Previous sleep study prior to enrollment done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care:

      1. overall AHI 5-40 events/hr.
      2. at least 10% time spent in the supine and 10% time in the non-supine positions.
      3. APOC I and APOC II
      4. central respiratory events < 50% of the total number of apneas and hypopneas
    • Using at least a queen-sized mattress when sleeping at home
    • Patients who meet the above criteria who have been prescribed CPAP or dental device but are non-adherent to treatment will be enrolled in the study. CPAP non-adherence will be defined as average nightly use < 4hrs/night based on a download of the CPAP machine, or self- acknowledged discontinuation or non-regular of CPAP use.

Exclusion Criteria:

  • • Incapable of giving informed consent

    • Under the age of 18
    • Active titration of medication
    • Pregnancy, lactation (will be screened with urine pregnancy test)
    • Self-reported Substance abuse (current)

    • Excessive alcohol consumption

      • Excessive alcohol use is defined as:
      • More than 3 glasses of wine a day
      • More than 3 beers a day
      • More than 60 mL of hard liquor a day
    • Use of home oxygen
    • Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score > 16 or a prior history of falling asleep while driving
    • Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD).
    • Unstable medical problem such as uncontrolled hypertension.
    • Body Mass Index (BMI) >45 kg/m2
    • Any other clinically significant condition that, in the opinion of the investigators, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wave Mattress Support

Arm Description

The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. The subject will sleep on mattress support for the duration of study participation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 30, 2019
Last Updated
February 22, 2021
Sponsor
Ohio State University
Collaborators
Hill-Rom
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1. Study Identification

Unique Protocol Identification Number
NCT03971721
Brief Title
Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home
Official Title
A Feasibility Study to Determine the Effects of a Novel Mattress Support for Treatment of Positional Obstructive Sleep Apnea at Home
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Funding stopped
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Hill-Rom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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). Determine the effects of Wave 4.3 on subjective measures of sleepiness and daytime function in patients with positional OSA. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Positional therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wave Mattress Support
Arm Type
Experimental
Arm Description
The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. The subject will sleep on mattress support for the duration of study participation.
Intervention Type
Device
Intervention Name(s)
Wave 4.3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index Difference Between Two Nights
Description
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
Secondary Outcome Measure Information:
Title
Oxygen Desaturation Index Difference Between Two Nights
Description
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
Title
Epworth Sleepiness Score
Description
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)
Title
Functional Outcomes of Sleep Questionnaire Score
Description
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)
Title
Visual Analog Scale Score
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 18-75 years of age Willing and able to give informed consent Able to speak and understand English Previous sleep study prior to enrollment done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care: overall AHI 5-40 events/hr. at least 10% time spent in the supine and 10% time in the non-supine positions. APOC I and APOC II central respiratory events < 50% of the total number of apneas and hypopneas Using at least a queen-sized mattress when sleeping at home Patients who meet the above criteria who have been prescribed CPAP or dental device but are non-adherent to treatment will be enrolled in the study. CPAP non-adherence will be defined as average nightly use < 4hrs/night based on a download of the CPAP machine, or self- acknowledged discontinuation or non-regular of CPAP use. Exclusion Criteria: • Incapable of giving informed consent Under the age of 18 Active titration of medication Pregnancy, lactation (will be screened with urine pregnancy test) Self-reported Substance abuse (current) Excessive alcohol consumption Excessive alcohol use is defined as: More than 3 glasses of wine a day More than 3 beers a day More than 60 mL of hard liquor a day Use of home oxygen Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score > 16 or a prior history of falling asleep while driving Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD). Unstable medical problem such as uncontrolled hypertension. Body Mass Index (BMI) >45 kg/m2 Any other clinically significant condition that, in the opinion of the investigators, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulysses Magalang, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home

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