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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01785199
• Other study ID #: UWB-C-008
• Status: Recruiting
• Phase: Phase 1
• First received: January 31, 2013
• Last updated: October 8, 2013
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: Mackay Memorial Hospital
• Contact: Ching-Lung Liu, MD
• Phone: +886-2-28094661
• Email: lraphael.tw[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Respiratory Aspiration
• Sleep Apnea, Obstructive
• Sleep-disordered Breathing

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital, Tamshui Branch	New Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Mackay Memorial Hospital	Seda Chemical Products Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes