Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea

Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea.

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Other: Wave sleep surface

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University Martha Morehouse Medical Pavilion 2050 Kenny Rd;Ste 2600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wave Surface, Then Non Wave Surface; Subjects sleep first for a whole night in the sleep laboratory with the Wave sleep surface. They then return to the sleep laboratory and sleep without the Wave sleep surface.	Other: Wave sleep surface; The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.
Experimental: Non Wave Surface, Then Wave Surface; Subjects sleep first for a whole night in the sleep laboratory without the Wave sleep surface. They then return to the sleep laboratory and sleep with the Wave sleep surface.	Other: Wave sleep surface; The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea Index (AHI)- Intention to Treat Analysis	AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep. These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea. This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.	measured during each of the two sleep study sessions (Study Visits 2 and 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Sleep Quality	Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3.	measured during each of the two sleep study sessions (Study Visits 2 and 3)
Sleep Efficiency	Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3. Sleep efficiency is defined as the total sleep time divided by the total recording time X100.	measured during each of the two sleep study sessions (Study Visits 2 and 3)

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Hill-Rom
• Investigators: Principal Investigator: Ulysses J Magalang, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: July 7, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2014H0235