Sleep-wake Analysis Clinical Trial
| NCT number | NCT02412527 |
| Other study ID # | 103-5603B |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | April 1, 2015 |
| Last updated | April 6, 2015 |
| Start date | April 2015 |
Objective: Computerized sleep staging has been verified in a normal population. This study
attempts to investigate and verify the interpretation of this computerized sleep staging
program in patients with sleep disorders, and improve the accuracy of actigraphy algorithm
for sleep duration and postures.
1. Compare the accuracy of computerized sleep-wake analysis with current sleep quality
indicators: through actigraphy and heart rate sensors, compare the computerized
sleep-wake analysis program with polysomnography, and verify its clinical reliability
and validity in sleep disorder patients.
2. Establish the sleep posture detection system: through three-axis accelerometer, develop
algorithms for position recording and monitoring during sleep, and upgrade its accuracy
according to photography.
Methods: Patients ranged from age 20-50 with primary insomnia, periodic limb movement in
sleep, simple snores, and obstructive sleep apnea will be enrolled in our study. Routine
polysomnography will be applied in sleep center at Chang Gung Memorial Hospital, Taoyuan, as
well as sleep-related questionnaires. At the same time, actigraphy and heart rate sensor
patch will be used for sleep posture detection and further computerized sleep-wake analysis.
Results will be verified the consistency by comparison with sleep-wake analysis from
polysomnographic data and sleep-related questionnaires.
| Status | Not yet recruiting |
| Enrollment | 330 |
| Est. completion date | |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - age 20-50 - diagnosed as primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea Exclusion Criteria: - arrhythmia - sleep efficiency<50% - combined other sleep disorders |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Chang Gung Memorial Hospital | National Yang Ming University |
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Electrocardiogram and body position signals | Computerized sleep-wake analysis from electrocardiogram and body position signals from Patch III heart rate sensor, and calibrated the sleep staging with AASM sleep scoring reports. | Data recruited during one-night (PSG study) from Patch III heart rate sensor | No |