Sleep Apnea, ObstructiveNCT01699139
The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke
A study testing positional device and lumbar corset in people with Sleep Apnea, Obstructive and Brain Ischemia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Supine positioning was reported to increase upper airway collapsibility, apnea frequency and duration. Positional therapy, designed to minimize supine sleep, was reported to be beneficial in the general sleep apnea population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Brain Ischemia
- What is being tested?
- positional device and lumbar corset
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Jul 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ischemic stroke (> 1month, within 12 months) and moderate-to-severe OSA (AHI>15) who could wear the positional devices not interfering with his/her sleep.
Who cannot join
- unclear consciousness
- unstable vital sign or neurologic sign
- unstable medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Supine positioning was reported to increase upper airway collapsibility, apnea frequency and duration. Positional therapy, designed to minimize supine sleep, was reported to be beneficial in the general sleep apnea population. As supine sleep is very common in stroke patients, positional therapy might also have therapeutic effects. Given differences between stroke patients with sleep apnea and the general sleep apnea patient, such as rolling ability, body mass index and daytime sleepiness, positional therapy results in the general population may not be applicable to the stroke patient.
The effects of positional therapy in ischemic stroke patients with OSA have not been well-investigated. We therefore performed a pilot randomized, controlled, cross-over study to test the following hypotheses: (1) positional therapy reduces the amount of nocturnal supine positioning in patients with subacute ischemic stroke, and (2) severity of sleep apnea improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The tolerability of positional therapy over a 3-month period in patients with ischemic stroke was also evaluated.
Read the detailed description
Phase 1:
In the first phase, a randomized, controlled, two-period cross-over study design (AB/BA) was used with no washout period. After an acclimatization period (3 days), during which the compliance of the Positional Device was monitored, each patient was randomized into either Group I (sequence AB) or Group II (sequence BA). After commencement of treatment, the outcome measures were repeated on the last day of each treatment period. On the control night (B), subjects used the lumbar corset and were positioned ad lib.
Phase 2:
In the second phase of the study which began immediately after attainment of the first phase, subjects were randomized on a 1:1 basis, in a parallel group design, to 3 months of positional devices or sleeping ad lib. At 3 months later all subjects were interviewed face to face to determine the Barthel index and the Patient Health Questionnaire 9-item depression scale. Subjects in the positional devices group were also evaluated about devices adherence using the following questions: use of the device all nights, most nights, some nights, or no nights.
- Conditions
- Sleep Apnea, Obstructive, Brain Ischemia
- Being tested
- positional device, lumbar corset
- Keywords
- supine position
- Medical subject headings
- Sleep Apnea, Obstructive, Brain Ischemia, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positional deviceDevice
Avoidance of supine positioning was achieved by use of the commercially available ZZoma Positional Device, which is the FDA cleared class II positional medical device. The device is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam. It is contained in the nylon material with an associated Velcro belt. Zzoma is a positioner worn around the upper torso to restrict patient movement from side to supine.
lumbar corsetDevice
Also called brand name: HEAVY-DUTY WAIST BINDER
A lumbar (abdominal) binder is made of an elastic fabric with Velcro closure. Subjects wore the prefabricated lumbar corset during sleep and were positioned ad lib.
| Study group | Role | What they receive |
|---|---|---|
| positional device | Active comparator | Not described Receives: Device: positional device |
| lumbar corset | Sham comparator | Not described Receives: Device: lumbar corset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in apnea-hypopnea index (AHI)
The AHI was defined as the average number of apneas and hypopneas per hour of sleep.
Measured: change from baseline in apnea-hypopnea index at 1 week and change from baseline in apnea-hypopnea index at 2 weeks
Secondary outcomes (5)
Change in Augmentation Index
The shape of the pressure waveform of an artery provides a measure of arterial stiffness and can be assessed by the technique of pulse wave analysis. Radial artery pulse waveforms were recorded using a pressure tonometer and dedicated software as previously described (SphygmoCor; At-Cor Medical, Sydney, Australia). Augmentation index, which quantifies augmentation of central aortic pressure (due to the reflected component of the pulse pressure waveform) and typically increases with age as the arteries become less compliant, is then calculated as the difference between the second (P2) and first systolic peak pressure (P1), expressed as percentage of the central pulse pressure (PP):
Augmentation index (%) = ((P2-P1)/PP)×100(1)
Measured: Change from baseline in Augmentation Index at 1 week and change from baseline in Augmentation Index at 2 weeks
Change in pulse wave velocity
The SphygmoCor System measures the pulse wave velocity of the blood pressure waveform travelling between any two arterial sites that can be measured non-invasively. The velocity of the blood pressure pulse waveform is dependent on the stiffness of the artery along which the pulse is travelling. Measurements are performed by recording pressure waveforms at the carotid artery followed by the femoral artery, with an ECG signal recorded simultaneously.
Measured: Change from baseline in pulse wave velocity at 1 week and change from baseline in pulse wave velocity at 2 weeks
Change in 24-hour blood pressure profile
Measured: Change from baseline in 24-hour blood pressure profile at 1 week and change from baseline in 24-hour blood pressure profile at 2 weeks
Change in the Patient Health Questionnaire 9-item depression scale (PHQ-9)
Measured: Change from baseline in the PHQ-9 at 1 week, change from baseline in the PHQ-9 at 2 weeks and change from baseline in the PHQ-9 at 12 weeks
Change in the percentage of nocturnal supine positioning during sleep
Measured: Change from baseline in the percentage of nocturnal supine positioning at 1 week and change from baseline in the percentage of nocturnal supine positioning at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chungyao Chen, M.D., Principal investigator, Chang Gung Memorial Hospital, Keelung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699139
- Sponsor's protocol ID
- NSC101-2314-B-182A-111
- Status last verified
- Aug 2012
- First submitted
- 27 Sep 2012
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01699139
- Acronym / sponsor ID
- NSC101-2314-B-182A-111
- Conditions
- Sleep Apnea, Obstructive, Brain Ischemia
- Keywords
- supine position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Oct 2012 (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.
Supine positioning was reported to increase upper airway collapsibility, apnea frequency and duration. Positional therapy, designed to minimize supine sleep, was reported to be beneficial in the general sleep apnea population. As supine sleep is very common in stroke patients, positional therapy might also have therapeutic effects. Given differences between stroke patients with sleep apnea and the general sleep apnea patient, such as rolling ability, body mass index and daytime sleepiness, positional therapy results in the general population may not be applicable to the stroke patient.
The effects of positional therapy in ischemic stroke patients with OSA have not been well-investigated. We therefore performed a pilot randomized, controlled, cross-over study to test the following hypotheses: (1) positional therapy reduces the amount of nocturnal supine positioning in patients with subacute ischemic stroke, and (2) severity of sleep apnea improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The tolerability of positional therapy over a 3-month period in patients with ischemic stroke was also evaluated.
Detailed description
Phase 1:
In the first phase, a randomized, controlled, two-period cross-over study design (AB/BA) was used with no washout period. After an acclimatization period (3 days), during which the compliance of the Positional Device was monitored, each patient was randomized into either Group I (sequence AB) or Group II (sequence BA). After commencement of treatment, the outcome measures were repeated on the last day of each treatment period. On the control night (B), subjects used the lumbar corset and were positioned ad lib.
Phase 2:
In the second phase of the study which began immediately after attainment of the first phase, subjects were randomized on a 1:1 basis, in a parallel group design, to 3 months of positional devices or sleeping ad lib. At 3 months later all subjects were interviewed face to face to determine the Barthel index and the Patient Health Questionnaire 9-item depression scale. Subjects in the positional devices group were also evaluated about devices adherence using the following questions: use of the device all nights, most nights, some nights, or no nights.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positional device | Active comparator | Device: positional device |
| lumbar corset | Sham comparator | Device: lumbar corset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ischemic stroke (> 1month, within 12 months) and moderate-to-severe OSA (AHI>15) who could wear the positional devices not interfering with his/her sleep.
Key exclusion criteria (3 listed)
- unclear consciousness
- unstable vital sign or neurologic sign
- unstable medical conditions
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 |
|---|---|---|
| positional deviceAvoidance of supine positioning was achieved by use of the commercially available ZZoma Positional Device, which is the FDA cleared class II positional medical device. The device is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam. It is contained in the nylon material with an associated Velcro belt. Zzoma is a positioner worn around the upper torso to restrict patient movement from side to supine. | Device | positional device |
| lumbar corsetAlso: brand name: HEAVY-DUTY WAIST BINDERA lumbar (abdominal) binder is made of an elastic fabric with Velcro closure. Subjects wore the prefabricated lumbar corset during sleep and were positioned ad lib. | Device | lumbar corset |
Primary outcome
Change in apnea-hypopnea index (AHI)
Time frame: change from baseline in apnea-hypopnea index at 1 week and change from baseline in apnea-hypopnea index at 2 weeks
The AHI was defined as the average number of apneas and hypopneas per hour of sleep.
5 secondary outcomes
Change in Augmentation Index
Time frame: Change from baseline in Augmentation Index at 1 week and change from baseline in Augmentation Index at 2 weeks
Change in pulse wave velocity
Time frame: Change from baseline in pulse wave velocity at 1 week and change from baseline in pulse wave velocity at 2 weeks
Change in 24-hour blood pressure profile
Time frame: Change from baseline in 24-hour blood pressure profile at 1 week and change from baseline in 24-hour blood pressure profile at 2 weeks
Change in the Patient Health Questionnaire 9-item depression scale (PHQ-9)
Time frame: Change from baseline in the PHQ-9 at 1 week, change from baseline in the PHQ-9 at 2 weeks and change from baseline in the PHQ-9 at 12 weeks
Change in the percentage of nocturnal supine positioning during sleep
Time frame: Change from baseline in the percentage of nocturnal supine positioning at 1 week and change from baseline in the percentage of nocturnal supine positioning at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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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.
Chungyao Chen, M.D. principal investigator
Chang Gung Memorial Hospital, Keelung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positional device and lumbar corset in people with Sleep Apnea, Obstructive and Brain Ischemia, run by Chang Gung 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 3 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: finished, as of the sponsor's last update on 10 Feb 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apnea-hypopnea index (AHI) (time frame: change from baseline in apnea-hypopnea index at 1 week and change from baseline in apnea-hypopnea index at 2 weeks). 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 10 Feb 2015.