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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250417
• Other study ID #: 2014H0235
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: August 2015

Study information

• Verified date: July 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University Martha Morehouse Medical Pavilion 2050 Kenny Rd;Ste 2600	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)