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Effects of Head Elevation by a Bed on Sleep-disordered Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01785199
Recruitment Status : Unknown
Verified October 2013 by Ching-Lung Liu, Mackay Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : February 7, 2013
Last Update Posted : October 9, 2013
Sponsor:
Collaborator:
Seda Chemical Products Co., Ltd.
Information provided by (Responsible Party):
Ching-Lung Liu, Mackay Memorial Hospital

Tracking Information
First Submitted Date  ICMJE January 31, 2013
First Posted Date  ICMJE February 7, 2013
Last Update Posted Date October 9, 2013
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2013)
Reduction of AHI score. [ Time Frame: Two full-night PSGs will be performed within one month ]
Using an automatic adjustable bed will improve sleep-disordered breathing with a reduction of AHI score is assumed.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Head Elevation by a Bed on Sleep-disordered Breathing
Official Title  ICMJE Effects of Head Elevation by an Adjustable Bed on Sleep-disordered Breathing
Brief Summary Sleep is known to be a dynamic state of consciousness that is characterized by rapid fluctuations in autonomic activity as well as changes in body postures. Body postures during sleep influence the severity of sleep-disordered breathing because a supine position is associated with an increase in upper airway collapsibility and thus an increase in frequency and duration of snoring and apnea. Use of an adjustable bed to elevate patients' head might improve those conditions. The purpose of the present study is to determine whether use of an automatic adjustable bed is associated with reducing sleep-disordered breathing in patients with suspected obstructive sleep apnea (OSA) due to upper airway problems.
Detailed Description

From the Chest and Otorhinolaryngology Department, patients with symptomatic sleep-disordered breathing will be referred to the Sleep Center. After an interview these subjects will undergo a full-night polysomnography (PSG). Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month. The automatic device is initiated when the patient suffers from apnea ≥ 10 seconds, which is detected by an ultra-wideband (UWB) sensor placed under the bed. The head will be slightly elevated at an angle of 10 degrees lasting 10 seconds and then be put down softly. Parameters of sleep efficiency and architecture, apnea-hypopnea index (AHI), and oxygen saturation will be obtained during each PSG. According to the severity, enrolled patients will be classified into 4 groups as normal (AHI < 5), mild OSA (AHI between 5 and 15), moderate OSA (AHI between 15 and 30) and severe OSA (AHI > 30).

Using an automatic adjustable bed will improve sleep-disordered breathing with a reduction of AHI score is assumed. The minimal sample size is estimated to be 14 subjects per group with the intention of providing 80% power and an overall two-sided 5% type I error. A total of 60 subjects (15 subjects per group) will be enrolled to achieve the necessary number of evaluable subjects, anticipating roughly a 10% drop-out rate.

Informed written consent will be obtained from all subjects. This study was approved by the Mackay Memorial Hospital Institutional Review Board.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep-disordered Breathing
  • Obstructive Sleep Apnea
Intervention  ICMJE Procedure: Head elevation by an automatic adjustable bed
The automatic device is initiated when the patient suffers from apnea ≥ 10 seconds, which is detected by an ultra-wideband (UWB) sensor placed under the bed. The head will be slightly elevated at an angle of 10 degrees lasting 10 seconds and then be put down softly.
Study Arms  ICMJE
  • Placebo Comparator: normal (AHI < 5)
    Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.
    Intervention: Procedure: Head elevation by an automatic adjustable bed
  • Active Comparator: mild OSA (AHI between 5 and 15)
    Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.
    Intervention: Procedure: Head elevation by an automatic adjustable bed
  • Active Comparator: moderate OSA (AHI between 15 and 30)
    Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.
    Intervention: Procedure: Head elevation by an automatic adjustable bed
  • Active Comparator: severe OSA (AHI > 30)
    Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.
    Intervention: Procedure: Head elevation by an automatic adjustable bed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 4, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects known to have snoring or sleep-disordered breathing

Exclusion Criteria:

  • Refusal to participate
  • Pregnancy
  • Psychiatric disorders
  • Clinical instability in the previous month
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01785199
Other Study ID Numbers  ICMJE UWB-C-008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ching-Lung Liu, Mackay Memorial Hospital
Study Sponsor  ICMJE Mackay Memorial Hospital
Collaborators  ICMJE Seda Chemical Products Co., Ltd.
Investigators  ICMJE
Principal Investigator: Ching-Lung Liu, MD Sleep Center, Mackay Memorial Hospital
PRS Account Mackay Memorial Hospital
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP