Suspended

Effects of Head Elevation by an Adjustable Bed on Sleep-disordered Breathing

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What is being tested

Head elevation by an automatic adjustable bed

Procedure
Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

From 20 to 70 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: October 2013
See protocol details

Summary

Principal SponsorMackay Memorial Hospital
Study ContactChing-Lung Liu, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleEffects of Head Elevation by an Adjustable Bed on Sleep-disordered Breathing
NCT01785199
Principal SponsorMackay Memorial Hospital
Study ContactChing-Lung Liu, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Apnea, ObstructiveSleep Disorders, IntrinsicDyssomnias

Criteria

1 inclusion criteria required to participate
Subjects known to have snoring or sleep-disordered breathing

4 exclusion criteria prevent from participating
Refusal to participate

Pregnancy

Psychiatric disorders

Clinical instability in the previous month

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Mackay Memorial Hospital, Tamshui Branch

New Taipei City, TaiwanOpen Mackay Memorial Hospital, Tamshui Branch in Google Maps
SuspendedOne Study Center
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