Sleep-wake AnalysisNCT02412527
Verification of Computerized Sleep-wake Analysis in Sleep Disorders
An observational study of Sleep-wake Analysis, run by Chang Gung Memorial Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sleep-wake Analysis
- What is being tested?
- Patch III heart rate sensor
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2016
- Phase
- Observational
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients ranged from age 20-50 with primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea will be enrolled.
Who may be able to join
- age 20-50
- diagnosed as primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea
Who cannot join
- arrhythmia
- sleep efficiency<50%
- combined other sleep disorders
Trial locations and contacts
No sites are listed yet.
About this study
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.
- 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.
- 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.
- Conditions
- Sleep-wake Analysis
- Being tested
- Patch III heart rate sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch III heart rate sensorOther
| Study group | Role | What they receive |
|---|---|---|
| Primary insomnia | Primary insomnia patients, without combined any other sleep disorders Receives: Other: Patch III heart rate sensor | |
| Periodic limb movement in sleep | Patients have periodic limb movement in sleep, without combined any other sleep disorders Receives: Other: Patch III heart rate sensor | |
| Simple snores | Simple snore patients, without combined any other sleep disorders Receives: Other: Patch III heart rate sensor | |
| Obstructive sleep apnea | Obstructive sleep apnea patients, including mild, moderate and severe types, without combined any other sleep disorders or CPAP treatment during PSG study Receives: Other: Patch III heart rate sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data recruited during one-night (PSG study) from Patch III heart rate sensor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Sleep-wake AnalysisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Principal investigator, Geng-Hao Liu, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412527
- Sponsor's protocol ID
- 103-5603B
- Status last verified
- Apr 2015
- First submitted
- 1 Apr 2015
- Last updated
- 9 Apr 2015
- Results posted
- No
Publications
Yang CC, Lai CW, Lai HY, Kuo TB. Relationship between electroencephalogram slow-wave magnitude and heart rate variability during sleep in humans. Neurosci Lett. 2002 Aug 30;329(2):213-6. doi: 10.1016/s0304-3940(02)00661-4.
PubMed 12165415Kuo TB, Yang CC. Frequency domain analysis of electrooculogram and its correlation with cardiac sympathetic function. Exp Neurol. 2009 May;217(1):38-45. doi: 10.1016/j.expneurol.2009.01.012. Epub 2009 Jan 31.
PubMed 19416676Kuo TB, Chen CY, Hsu YC, Yang CC. Performance of the frequency domain indices with respect to sleep staging. Clin Neurophysiol. 2012 Jul;123(7):1338-45. doi: 10.1016/j.clinph.2011.11.003. Epub 2011 Dec 5.
PubMed 22153785Sadeh A. The role and validity of actigraphy in sleep medicine: an update. Sleep Med Rev. 2011 Aug;15(4):259-67. doi: 10.1016/j.smrv.2010.10.001. Epub 2011 Jan 14.
PubMed 21237680Lindemann U, Hock A, Stuber M, Keck W, Becker C. Evaluation of a fall detector based on accelerometers: a pilot study. Med Biol Eng Comput. 2005 Sep;43(5):548-51. doi: 10.1007/BF02351026.
PubMed 16411625Paquet J, Kawinska A, Carrier J. Wake detection capacity of actigraphy during sleep. Sleep. 2007 Oct;30(10):1362-9. doi: 10.1093/sleep/30.10.1362.
PubMed 17969470Cole RJ, Kripke DF, Gruen W, Mullaney DJ, Gillin JC. Automatic sleep/wake identification from wrist activity. Sleep. 1992 Oct;15(5):461-9. doi: 10.1093/sleep/15.5.461.
PubMed 1455130Tryon WW. Issues of validity in actigraphic sleep assessment. Sleep. 2004 Feb 1;27(1):158-65. doi: 10.1093/sleep/27.1.158.
PubMed 14998254Hedner J, Pillar G, Pittman SD, Zou D, Grote L, White DP. A novel adaptive wrist actigraphy algorithm for sleep-wake assessment in sleep apnea patients. Sleep. 2004 Dec 15;27(8):1560-6. doi: 10.1093/sleep/27.8.1560.
PubMed 15683148Murayama R, Kubota T, Kogure T, Aoki K. The effects of instruction regarding sleep posture on the postural changes and sleep quality among middle-aged and elderly men: a preliminary study. Biosci Trends. 2011;5(3):111-9. doi: 10.5582/bst.2011.v5.3.111.
PubMed 21788696Wrzus C, Brandmaier AM, von Oertzen T, Muller V, Wagner GG, Riediger M. A new approach for assessing sleep duration and postures from ambulatory accelerometry. PLoS One. 2012;7(10):e48089. doi: 10.1371/journal.pone.0048089. Epub 2012 Oct 24.
PubMed 23110178Bignold JJ, Mercer JD, Antic NA, McEvoy RD, Catcheside PG. Accurate position monitoring and improved supine-dependent obstructive sleep apnea with a new position recording and supine avoidance device. J Clin Sleep Med. 2011 Aug 15;7(4):376-83. doi: 10.5664/JCSM.1194.
PubMed 21897774de Souza L, Benedito-Silva AA, Pires ML, Poyares D, Tufik S, Calil HM. Further validation of actigraphy for sleep studies. Sleep. 2003 Feb 1;26(1):81-5. doi: 10.1093/sleep/26.1.81.
PubMed 12627737Silber MH, Ancoli-Israel S, Bonnet MH, Chokroverty S, Grigg-Damberger MM, Hirshkowitz M, Kapen S, Keenan SA, Kryger MH, Penzel T, Pressman MR, Iber C. The visual scoring of sleep in adults. J Clin Sleep Med. 2007 Mar 15;3(2):121-31.
PubMed 17557422Ahlberg K, Savolainen A, Paju S, Hublin C, Partinen M, Kononen M, Ahlberg J. Bruxism and sleep efficiency measured at home with wireless devices. J Oral Rehabil. 2008 Aug;35(8):567-71. doi: 10.1111/j.1365-2842.2008.01875.x. Epub 2008 May 9.
PubMed 18482341
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Computerized Sleep-wake Analysis in Sleep Disorders
- ClinicalTrials.gov ID
- NCT02412527
- Acronym / sponsor ID
- 103-5603B
- Conditions
- Sleep-wake Analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- First posted
- 9 Apr 2015 (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.
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.
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary insomnia | – | Other: Patch III heart rate sensorPrimary insomnia patients, without combined any other sleep disorders |
| Periodic limb movement in sleep | – | Other: Patch III heart rate sensorPatients have periodic limb movement in sleep, without combined any other sleep disorders |
| Simple snores | – | Other: Patch III heart rate sensorSimple snore patients, without combined any other sleep disorders |
| Obstructive sleep apnea | – | Other: Patch III heart rate sensorObstructive sleep apnea patients, including mild, moderate and severe types, without combined any other sleep disorders or CPAP treatment during PSG study |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients ranged from age 20-50 with primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea will be enrolled.
Key inclusion criteria (2 listed)
- age 20-50
- diagnosed as primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea
Key exclusion criteria (3 listed)
- arrhythmia
- sleep efficiency<50%
- combined other sleep disorders
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 |
|---|---|---|
| Patch III heart rate sensor | Other | Obstructive sleep apnea, Periodic limb movement in sleep, Primary insomnia, Simple snores |
Primary outcome
Electrocardiogram and body position signals
Time frame: Data recruited during one-night (PSG study) from Patch III heart rate sensor
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Results publication: PubMed 12165415Yang CC, Lai CW, Lai HY, Kuo TB. Relationship between electroencephalogram slow-wave magnitude and heart rate variability during sleep in humans. Neurosci Lett. 2002 Aug 30;329(2):213-6. doi: 10.1016/s0304-3940(02)00661-4.
- Results publication: PubMed 19416676Kuo TB, Yang CC. Frequency domain analysis of electrooculogram and its correlation with cardiac sympathetic function. Exp Neurol. 2009 May;217(1):38-45. doi: 10.1016/j.expneurol.2009.01.012. Epub 2009 Jan 31.
- Results publication: PubMed 22153785Kuo TB, Chen CY, Hsu YC, Yang CC. Performance of the frequency domain indices with respect to sleep staging. Clin Neurophysiol. 2012 Jul;123(7):1338-45. doi: 10.1016/j.clinph.2011.11.003. Epub 2011 Dec 5.
- Results publication: PubMed 21237680Sadeh A. The role and validity of actigraphy in sleep medicine: an update. Sleep Med Rev. 2011 Aug;15(4):259-67. doi: 10.1016/j.smrv.2010.10.001. Epub 2011 Jan 14.
- Results publication: PubMed 16411625Lindemann U, Hock A, Stuber M, Keck W, Becker C. Evaluation of a fall detector based on accelerometers: a pilot study. Med Biol Eng Comput. 2005 Sep;43(5):548-51. doi: 10.1007/BF02351026.
- Results publication: PubMed 17969470Paquet J, Kawinska A, Carrier J. Wake detection capacity of actigraphy during sleep. Sleep. 2007 Oct;30(10):1362-9. doi: 10.1093/sleep/30.10.1362.
- Results publication: PubMed 1455130Cole RJ, Kripke DF, Gruen W, Mullaney DJ, Gillin JC. Automatic sleep/wake identification from wrist activity. Sleep. 1992 Oct;15(5):461-9. doi: 10.1093/sleep/15.5.461.
- Results publication: PubMed 14998254Tryon WW. Issues of validity in actigraphic sleep assessment. Sleep. 2004 Feb 1;27(1):158-65. doi: 10.1093/sleep/27.1.158.
- Results publication: PubMed 15683148Hedner J, Pillar G, Pittman SD, Zou D, Grote L, White DP. A novel adaptive wrist actigraphy algorithm for sleep-wake assessment in sleep apnea patients. Sleep. 2004 Dec 15;27(8):1560-6. doi: 10.1093/sleep/27.8.1560.
- Results publication: PubMed 21788696Murayama R, Kubota T, Kogure T, Aoki K. The effects of instruction regarding sleep posture on the postural changes and sleep quality among middle-aged and elderly men: a preliminary study. Biosci Trends. 2011;5(3):111-9. doi: 10.5582/bst.2011.v5.3.111.
- Results publication: PubMed 23110178Wrzus C, Brandmaier AM, von Oertzen T, Muller V, Wagner GG, Riediger M. A new approach for assessing sleep duration and postures from ambulatory accelerometry. PLoS One. 2012;7(10):e48089. doi: 10.1371/journal.pone.0048089. Epub 2012 Oct 24.
- Results publication: PubMed 21897774Bignold JJ, Mercer JD, Antic NA, McEvoy RD, Catcheside PG. Accurate position monitoring and improved supine-dependent obstructive sleep apnea with a new position recording and supine avoidance device. J Clin Sleep Med. 2011 Aug 15;7(4):376-83. doi: 10.5664/JCSM.1194.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep-wake Analysis, run by Chang Gung Memorial Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geng-Hao Liu (+886-3-3196200 ext. 2613, wisdomhao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrocardiogram and body position signals (time frame: Data recruited during one-night (PSG study) from Patch III heart rate sensor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02412527, which also lists 15 linked publications.
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 Apr 2015.