Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home

The Ohio State University

Status: Terminated

Conditions: Sleep Apnea, Obstructive

Treatments: Device: Wave 4.3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03971721

2019H0025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Wave Mattress Support

Experimental group

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.

Treatment:

Device: Wave 4.3