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

Primary Purpose

Sleep-disordered Breathing, Obstructive Sleep Apnea

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Head elevation by an automatic adjustable bed
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep-disordered Breathing focused on measuring apnea-hypopnea index, obstructive sleep apnea, body posture, ultra-wideband

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mackay Memorial Hospital, Tamshui BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

normal (AHI < 5)

mild OSA (AHI between 5 and 15)

moderate OSA (AHI between 15 and 30)

severe OSA (AHI > 30)

Arm Description

Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.

Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.

Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.

Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.

Outcomes

Primary Outcome Measures

Reduction of AHI score.
Using an automatic adjustable bed will improve sleep-disordered breathing with a reduction of AHI score is assumed.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2013
Last Updated
October 8, 2013
Sponsor
Mackay Memorial Hospital
Collaborators
Seda Chemical Products Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01785199
Brief Title
Effects of Head Elevation by a Bed on Sleep-disordered Breathing
Official Title
Effects of Head Elevation by an Adjustable Bed on Sleep-disordered Breathing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital
Collaborators
Seda Chemical Products Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-disordered Breathing, Obstructive Sleep Apnea
Keywords
apnea-hypopnea index, obstructive sleep apnea, body posture, ultra-wideband

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
normal (AHI < 5)
Arm Type
Placebo Comparator
Arm Description
Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.
Arm Title
mild OSA (AHI between 5 and 15)
Arm Type
Active Comparator
Arm Description
Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.
Arm Title
moderate OSA (AHI between 15 and 30)
Arm Type
Active Comparator
Arm Description
Patients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month.
Arm Title
severe OSA (AHI > 30)
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Head elevation by an automatic adjustable bed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of AHI score.
Description
Using an automatic adjustable bed will improve sleep-disordered breathing with a reduction of AHI score is assumed.
Time Frame
Two full-night PSGs will be performed within one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Lung Liu, MD
Phone
+886-2-28094661
Ext
2863
Email
lraphael.tw@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Lung Liu, MD
Organizational Affiliation
Sleep Center, Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital, Tamshui Branch
City
New Taipei City
ZIP/Postal Code
25160
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Lung Liu, MD
Phone
+886-2-28094661
Ext
2863
Email
lraphael.tw@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Ching-Lung Liu, MD

12. IPD Sharing Statement

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

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