Effects of Head Elevation by an Adjustable Bed on Sleep-disordered Breathing
Head elevation by an automatic adjustable bed
Apnea+6
+ Nervous System Diseases
+ Respiration Disorders
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
PlaceboGroup IV
Active ComparatorStudy 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
Mackay Memorial Hospital, Tamshui Branch
New Taipei City, TaiwanOpen Mackay Memorial Hospital, Tamshui Branch in Google Maps