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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep-disordered Breathing Obstructive Sleep Apnea Procedure: Head elevation by an automatic adjustable bed Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Head Elevation by an Adjustable Bed on Sleep-disordered Breathing
Study Start Date : October 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785199


Contacts
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Contact: Ching-Lung Liu, MD +886-2-28094661 ext 2863 lraphael.tw@yahoo.com.tw

Locations
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Taiwan
Mackay Memorial Hospital, Tamshui Branch Recruiting
New Taipei City, Taiwan, 25160
Contact: Ching-Lung Liu, MD    +886-2-28094661 ext 2863    lraphael.tw@yahoo.com.tw   
Principal Investigator: Ching-Lung Liu, MD         
Sponsors and Collaborators
Mackay Memorial Hospital
Seda Chemical Products Co., Ltd.
Investigators
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Principal Investigator: Ching-Lung Liu, MD Sleep Center, Mackay Memorial Hospital
More Information
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Responsible Party: Ching-Lung Liu, MD, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01785199    
Other Study ID Numbers: UWB-C-008
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013
Keywords provided by Ching-Lung Liu, Mackay Memorial Hospital:
apnea-hypopnea index
obstructive sleep apnea
body posture
ultra-wideband
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Aspiration
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes