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Completed

NCT Number: NCT02250417

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Martha Morehouse Medical Pavilion 2050 Kenny Rd;Ste 2600

Columbus, Ohio, 43221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wave sleep surface

Other

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.

Primary outcomes

  1. Apnea-hypopnea Index (AHI)- Intention to Treat Analysis

    Time frame: measured during each of the two sleep study sessions (Study Visits 2 and 3)

    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.

Secondary outcomes

  1. Objective Sleep Quality

    Time frame: measured during each of the two sleep study sessions (Study Visits 2 and 3)

    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.

  2. Sleep Efficiency

    Time frame: measured during each of the two sleep study sessions (Study Visits 2 and 3)

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Hill-Rom

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2014
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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