Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home

NCT ID: NCT03971721

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-01-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wave Mattress Support

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.

Group Type: EXPERIMENTAL

Wave 4.3

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hill-Rom

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Ulysses Magalang MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulysses Magalang, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019H0025

Identifier Type: -

Identifier Source: org_study_id