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

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. |
- 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.

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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 |
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

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
Contact: Ching-Lung Liu, MD | +886-2-28094661 ext 2863 | lraphael.tw@yahoo.com.tw |
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 |
Principal Investigator: | Ching-Lung Liu, MD | Sleep Center, Mackay Memorial Hospital |
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 |
apnea-hypopnea index obstructive sleep apnea body posture ultra-wideband |
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 |