Clinical trial NCT02250417: Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea
Official title: Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Hill-Rom
First posted: 2014-09-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI is the number of times per hour of sleep that the airway temporarily collapses at the level of the tongue or soft palate. In a significant number of individuals with OSA, the severity of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine (back) position and lowers in the lateral (side) position. This is called positional OSA.

The primary objective of this study is to determine whether sleeping with a novel sleep surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those with positional OSA.

Detailed description: The primary objective of this study is to determine whether sleeping with the novel device (Wave sleep surface) reduces the AHI in those with supine position-related OSA, also known as positional OSA. A secondary aim is to determine the effects of the sleep surface on subjective and objective measures of sleep in patients with positional OSA.

Eligibility criteria: Inclusion Criteria:

We will recruit subjects who are:

* 18 years of age and above
* Willing and able to give informed consent
* Prior sleep study done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care and performed no more than 12 months prior to enrollment that meets the following:

  * overall AHI 5-30 events/hr
  * at least 20 minutes of recorded sleep in the supine and nonsupine postures
  * positional OSA defined as \> 50% reduction in the AHI between the supine and nonsupine postures and AHI \< 5hr in the nonsupine position
  * central apneas \< 50% of the total number of apneas and hypopneas
* Patients who meet the above criteria who have been prescribed CPAP therapy but are non-compliant will be enrolled in the study. CPAP noncompliance will be defined as average nightly use \< 4hrs/night based on a download of the CPAP machine, or self- acknowledged discontinuation of CPAP use.

Exclusion Criteria:

* Incapable of giving informed consent
* Under the age of 18
* Known inability to sleep in the lateral position
* Active titration of medication
* 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
* Room air oxyhemoglobin saturation \< 88%
* Use of home oxygen
* Compliant with OSA therapy
* Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score \> 16 or a prior history of falling asleep while driving
* Unstable medical problem such as uncontrolled hypertension.
* Body Mass Index (BMI) \> 45 kg/m2

Primary outcomes:
measure: Apnea-hypopnea Index (AHI)- Intention to Treat Analysis
timeFrame: measured during each of the two sleep study sessions (Study Visits 2 and 3)
Secondary outcomes:
measure: Objective Sleep Quality
timeFrame: measured during each of the two sleep study sessions (Study Visits 2 and 3)
measure: Sleep Efficiency
timeFrame: measured during each of the two sleep study sessions (Study Visits 2 and 3)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Martha Morehouse Medical Pavilion 2050 Kenny Rd;Ste 2600
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ulysses J Magalang, MD
role: PRINCIPAL_INVESTIGATOR
References: