Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home

NCT03971721 | Terminated Results DMC FDA Device

• 1 other identifier: 2019H0025
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Determine the effects of Wave 4.3 on subjective measures of sleepiness and daytime function in patients with positional OSA.
3. 3.Determine the effects of Wave 4.3 on subjective measures of sleep quality in patients with positional OSA.

Conditions

Sleep Apnea, Obstructive

Keywords

Positional therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 nights

Secondary Outcomes (4)

• Oxygen Desaturation Index Difference Between Two Nights

  2 nights

• Epworth Sleepiness Score

  Completed at Visit 1 and Visit 4 (~5 minutes)

• Functional Outcomes of Sleep Questionnaire Score

  Completed at Visit 2 and Visit 4 (~5 minutes)

• Visual Analog Scale Score

  Completed at Visit 2 and Visit 4 (~5 minutes)

Study Arms (1)

Wave Mattress Support

EXPERIMENTAL

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.

Device: Wave 4.3

Interventions

Wave 4.3 DEVICE

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.

Wave Mattress Support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Hill-Rom: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Ulysses Magalang
• Organization: The Ohio State University

Ulysses.Magalang@osumc.edu

(614) 293-4925

Study Officials

• Ulysses Magalang, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: July 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 16, 2021
• Results First Posted: March 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)