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

NCT02250417 | Completed Results

• 1 other identifier: 2014H0235
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Objective Sleep Quality

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

• Sleep Efficiency

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

Study Arms (2)

Wave Surface, Then Non Wave Surface

EXPERIMENTAL

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

Non Wave Surface, Then Wave Surface

EXPERIMENTAL

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

Interventions

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.

Non Wave Surface, Then Wave Surface; Wave Surface, Then Non Wave Surface

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will recruit subjects who are:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Hill-Rom: collaborator

Study Sites (1)

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

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Ulysses J. Magalang
• Organization: The Ohio State University

magalang.1@osu.edu

614-292-6563

Study Officials

• Ulysses J Magalang, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 8, 2018
• Results First Posted: August 8, 2018

Record last verified: 2018-07

Locations

US (1)