Clinical trial NCT03971721: 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
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Positional therapy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Hill-Rom
First posted: 2019-06-03
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Apnea-Hypopnea Index Difference Between Two Nights
timeFrame: 2 nights
Secondary outcomes:
measure: Oxygen Desaturation Index Difference Between Two Nights
timeFrame: 2 nights
measure: Epworth Sleepiness Score
timeFrame: Completed at Visit 1 and Visit 4 (~5 minutes)
measure: Functional Outcomes of Sleep Questionnaire Score
timeFrame: Completed at Visit 2 and Visit 4 (~5 minutes)
measure: Visual Analog Scale Score
timeFrame: Completed at Visit 2 and Visit 4 (~5 minutes)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ulysses Magalang, MD
role: PRINCIPAL_INVESTIGATOR
References: