Back to results

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

Primary Purpose

Sleep Apnea, Obstructive

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wave sleep surface

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Wave Surface, Then Non Wave Surface

Non Wave Surface, Then Wave Surface

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02250417

First Posted

September 23, 2014

Last Updated

July 7, 2018

Sponsor

Ohio State University

Collaborators

Hill-Rom

1. Study Identification

Unique Protocol Identification Number

NCT02250417

Brief Title

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University

Collaborators

Hill-Rom

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wave Surface, Then Non Wave Surface

Arm Type

Experimental

Arm Description

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.

Arm Title

Non Wave Surface, Then Wave Surface

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Wave sleep surface

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Objective Sleep Quality

Description

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.

Time Frame

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

Title

Sleep Efficiency

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulysses J Magalang, MD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs