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

NCT01785199 | Unknown Phase 1 DMC

• 1 other identifier: UWB-C-008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep-disordered Breathing; Obstructive Sleep Apnea

Keywords

apnea-hypopnea index; obstructive sleep apnea; body posture; ultra-wideband

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

normal (AHI < 5)

PLACEBO 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.

Procedure: Head elevation by an automatic adjustable bed

mild OSA (AHI between 5 and 15)

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.

Procedure: Head elevation by an automatic adjustable bed

moderate OSA (AHI between 15 and 30)

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.

Procedure: Head elevation by an automatic adjustable bed

severe OSA (AHI > 30)

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.

Procedure: Head elevation by an automatic adjustable bed

Interventions

Head elevation by an automatic adjustable bed PROCEDURE

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.

mild OSA (AHI between 5 and 15); moderate OSA (AHI between 15 and 30); normal (AHI < 5); severe OSA (AHI > 30)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects known to have snoring or sleep-disordered breathing

You may not qualify if:

• Refusal to participate
• Pregnancy
• Psychiatric disorders
• Clinical instability in the previous month

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• Seda Chemical Products Co., Ltd.: collaborator

Study Sites (1)

Mackay Memorial Hospital, Tamshui Branch

New Taipei City, 25160, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ching-Lung Liu, MD

  Sleep Center, Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Lung Liu, MD

CONTACT

+886-2-28094661; lraphael.tw@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 7, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 9, 2013

Record last verified: 2013-10

Locations

TW (1)