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

• ClinicalTrials.gov Identifier: NCT02250417
• Recruitment Status: Completed
• First Posted: September 26, 2014
• Results First Posted: August 8, 2018
• Last Update Posted: August 8, 2018
• Sponsor: Ohio State University
• Collaborator: Hill-Rom
• Information provided by (Responsible Party): Ulysses Magalang MD, Ohio State University

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.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea, Obstructive	Other: Wave sleep surface	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea.
• Study Start Date: August 2014
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Ohio

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

Columbus, Ohio, United States, 43221

Sponsors and Collaborators

Ohio State University

Hill-Rom

Investigators

• Principal Investigator: Ulysses J Magalang, MD; Ohio State University

More Information

• Responsible Party: Ulysses Magalang MD, Professor of Medicine, Ohio State University
• ClinicalTrials.gov Identifier: NCT02250417
• Other Study ID Numbers: 2014H0235
• First Posted: September 26, 2014
• Results First Posted: August 8, 2018
• Last Update Posted: August 8, 2018
• Last Verified: July 2018

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases