Sleep-disordered BreathingPhase 1NCT01785199
Effects of Head Elevation by a Bed on Sleep-disordered Breathing
A Phase 1 study testing Head elevation by an automatic adjustable bed in people with Sleep-disordered Breathing and Obstructive Sleep Apnea, run by Mackay Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep-disordered Breathing, Obstructive Sleep Apnea
- What is being tested?
- Head elevation by an automatic adjustable bed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects known to have snoring or sleep-disordered breathing
Who cannot join
- Refusal to participate
- Pregnancy
- Psychiatric disorders
- Clinical instability in the previous month
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Mackay Memorial Hospital, Tamshui Branch
New Taipei City, 25160
Ching-Lung Liu, MD, +886-2-28094661 ext. 2863, lraphael.tw@yahoo.com.tw
Ching-Lung Liu, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Head elevation by an automatic adjustable bed
- Keywords
- apnea-hypopnea index, obstructive sleep apnea, body posture, ultra-wideband
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head elevation by an automatic adjustable bedProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Head elevation by an automatic adjustable bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of AHI score.
Using an automatic adjustable bed will improve sleep-disordered breathing with a reduction of AHI score is assumed.
Measured: Two full-night PSGs will be performed within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seda Chemical Products Co., Ltd.
- Responsible party
- Principal investigator, Ching-Lung Liu, Mackay Memorial Hospital
- Investigators
- Ching-Lung Liu, MD, Principal investigator, Sleep Center, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785199
- Sponsor's protocol ID
- UWB-C-008
- Status last verified
- Oct 2013
- First submitted
- 31 Jan 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Head Elevation by an Adjustable Bed on Sleep-disordered Breathing
- ClinicalTrials.gov ID
- NCT01785199
- Acronym / sponsor ID
- UWB-C-008
- Keywords
- apnea-hypopnea index, obstructive sleep apnea, body posture, ultra-wideband
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- Seda Chemical Products Co., Ltd.
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal (AHI < 5) | Placebo comparator | Procedure: Head elevation by an automatic adjustable bedPatients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month. |
| mild OSA (AHI between 5 and 15) | Active comparator | Procedure: Head elevation by an automatic adjustable bedPatients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month. |
| moderate OSA (AHI between 15 and 30) | Active comparator | Procedure: Head elevation by an automatic adjustable bedPatients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month. |
| severe OSA (AHI > 30) | Active comparator | Procedure: Head elevation by an automatic adjustable bedPatients who are eligible for this study will sleep on an automatic adjustable bed with a second PSG performed within the next one month. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects known to have snoring or sleep-disordered breathing
Key exclusion criteria (4 listed)
- Refusal to participate
- Pregnancy
- Psychiatric disorders
- Clinical instability in the previous month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head elevation by an automatic adjustable bedThe 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. | Procedure or surgery | mild OSA (AHI between 5 and 15), moderate OSA (AHI between 15 and 30), normal (AHI < 5), severe OSA (AHI > 30) |
Primary outcome
Reduction of AHI score.
Time frame: Two full-night PSGs will be performed within one month
Using an automatic adjustable bed will improve sleep-disordered breathing with a reduction of AHI score is assumed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Lung Liu, MD principal investigator
Sleep Center, Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Head elevation by an automatic adjustable bed in people with Sleep-disordered Breathing and Obstructive Sleep Apnea, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Lung Liu, MD (+886-2-28094661 ext. 2863, lraphael.tw@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of AHI score. (time frame: Two full-night PSGs will be performed within one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.