The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke

This study is currently recruiting participants.
Verified August 2012 by Chang Gung Memorial Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01699139
First received: September 27, 2012
Last updated: April 3, 2013
Last verified: August 2012

September 27, 2012
April 3, 2013
August 2012
July 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]
The AHI was defined as the average number of apneas and hypopneas per hour of sleep.
Same as current
Complete list of historical versions of study NCT01699139 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]

    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)

  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
  • Change in Barthel index [ Time Frame: Change from baseline in Barthel index at 1 week, change from baseline in Barthel index at 2 weeks and change from baseline in Barthel index at 12 weeks ] [ Designated as safety issue: No ]
  • Tolerability of the positional devices [ Time Frame: 12 weeks after wearing the positional devices ] [ Designated as safety issue: No ]
    Participants were asked to wear the positional devices for 3 months during sleep and were queried about devices adherence at the end of the study using the following questions: use of the device all nights, most nights, some nights, or no nights.
  • Change in Barthel index [ Time Frame: Change from baseline in Barthel index at 1 week, change from baseline in Barthel index at 2 weeks and change from baseline in Barthel index at 12 weeks ] [ Designated as safety issue: No ]
  • Tolerability of the positional devices [ Time Frame: 12 weeks after wearing the positional devices ] [ Designated as safety issue: No ]
    Participants were asked to wear the positional devices for 3 months during sleep and were queried about devices adherence at the end of the study using a Likert scale: use of the device all nights, most nights, some nights, or no nights.
 
The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke
The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Sleep Apnea, Obstructive
  • Brain Ischemia
  • Device: positional device
    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.
  • Device: lumbar corset
    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.
    Other Name: brand name: HEAVY-DUTY WAIST BINDER
  • Active Comparator: positional device
    Intervention: Device: positional device
  • Sham Comparator: lumbar corset
    Intervention: Device: lumbar corset
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • unclear consciousness
  • unstable vital sign or neurologic sign
  • unstable medical conditions
Both
18 Years and older
No
Contact: Chungyao Chen, M.D. 8862975360695 jongyau2002@gmail.com
Taiwan
 
NCT01699139
NSC101-2314-B-182A-111
Yes
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
National Science Council, Taiwan
Principal Investigator: Chungyao Chen, M.D. Chang Gung Memorial Hospital, Keelung
Chang Gung Memorial Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP