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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea; Sleep-disordered Breathing
• Intervention / Treatment: Procedure: Head elevation by an automatic adjustable bed

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ching-Lung Liu, MD; Phone Number: 2863 +886-2-28094661; Email: lraphael.tw@yahoo.com.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 25160
    • Recruiting
    • Mackay Memorial Hospital, Tamshui Branch
    • Contact: Ching-Lung Liu, MD; Phone Number: 2863 +886-2-28094661; Email: lraphael.tw@yahoo.com.tw
    • Principal Investigator: Ching-Lung Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of AHI score.	Using an automatic adjustable bed will improve sleep-disordered breathing with a reduction of AHI score is assumed.	Two full-night PSGs will be performed within one month

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Collaborators: Seda Chemical Products Co., Ltd.
• Investigators: Principal Investigator: Ching-Lung Liu, MD, Sleep Center, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: February 4, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Estimate): October 9, 2013
• Last Update Submitted That Met QC Criteria: October 8, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; body posture; apnea-hypopnea index; ultra-wideband
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration
• Other Study ID Numbers: UWB-C-008