Obstructive Sleep ApneaNCT00949858
New Data Analysis Methods for Actigraphy in Sleep Medicine
An observational study of Obstructive Sleep Apnea and Restless Leg Syndrome, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to develop statistical and informatics tools for analyzing and visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Restless Leg Syndrome, Insomnia
- How many people
- 635 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to 22 Jan 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen in clinic at the Washington University Sleep Medicine Center.
Who may be able to join
- Patient presenting to the Washington University Sleep Medicine Center for evaluation of obstructive sleep apnea syndrome, restless legs syndrome, or insomnia
- Older than 18 years of age
- Ability to consent to participation in the study
- Willingness to wear the Actical™ for two 7 day periods and to return the equipment promptly
Who cannot join
- Inability to provide valid consent
- Pregnancy
- Night or rotating shift workers
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Sleep Medicine Center
St Louis, Missouri, 63108
About this study
The purpose of this study is to develop statistical and informatics tools for analyzing and visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients.
Read the detailed description
An Actical™ is a watch-like device attached to the wrist that uses an accelerometer to measure movement nearly continuously over several days. The American Academy of Sleep Medicine practice parameters report that actigraphy is a useful tool for detecting sleep in healthy individuals, assessing specific aspects in insomnia and restless legs syndrome, circadian-rhythm disorders, and excessive sleepiness. Concurrent with these recommendations is an increased interest in the use of actigraphy as a tool for objectively measuring fatigue. With improved high-end statistical methods for analyzing this data, actigraphy has the potential to become more important as an objective diagnostic tool for determining fatigue, sleep abnormalities and assessing response to treatment.
- Conditions
- Obstructive Sleep Apnea, Restless Leg Syndrome, Insomnia
- Keywords
- Sleep Disorders, Obstructive Sleep Apnea, Restless Leg Syndrome, Insomnia, Actigraphy
- Medical subject headings
- Sleep Apnea, Obstructive, Restless Legs Syndrome, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Define an object oriented data model for actigraphy and patient level data.
Measured: 6 months
Secondary outcomes (1)
Apply existing and develop new advanced statistical and visualization methods for actigraphy data and include them in the data model listed above.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2014
- Study completion22 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Utah State University
- Responsible party
- Sponsor
- Investigators
- William Shannon, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949858
- Sponsor's protocol ID
- R01HL092347-01A1
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2009
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Data Analysis Methods for Actigraphy in Sleep Medicine
- ClinicalTrials.gov ID
- NCT00949858
- Acronym / sponsor ID
- R01HL092347-01A1
- Conditions
- Obstructive Sleep Apnea, Restless Leg Syndrome, Insomnia
- Keywords
- Sleep Disorders, Obstructive Sleep Apnea, Restless Leg Syndrome, Insomnia, Actigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Utah State University
- Study start
- Jul 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- 22 Jan 2014 (actual)
- First posted
- 30 Jul 2009 (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.
The purpose of this study is to develop statistical and informatics tools for analyzing and visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients.
Detailed description
An Actical™ is a watch-like device attached to the wrist that uses an accelerometer to measure movement nearly continuously over several days. The American Academy of Sleep Medicine practice parameters report that actigraphy is a useful tool for detecting sleep in healthy individuals, assessing specific aspects in insomnia and restless legs syndrome, circadian-rhythm disorders, and excessive sleepiness. Concurrent with these recommendations is an increased interest in the use of actigraphy as a tool for objectively measuring fatigue. With improved high-end statistical methods for analyzing this data, actigraphy has the potential to become more important as an objective diagnostic tool for determining fatigue, sleep abnormalities and assessing response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in clinic at the Washington University Sleep Medicine Center.
Key inclusion criteria (4 listed)
- Patient presenting to the Washington University Sleep Medicine Center for evaluation of obstructive sleep apnea syndrome, restless legs syndrome, or insomnia
- Older than 18 years of age
- Ability to consent to participation in the study
- Willingness to wear the Actical™ for two 7 day periods and to return the equipment promptly
Key exclusion criteria (3 listed)
- Inability to provide valid consent
- Pregnancy
- Night or rotating shift workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Define an object oriented data model for actigraphy and patient level data.
Time frame: 6 months
1 secondary outcome
Apply existing and develop new advanced statistical and visualization methods for actigraphy data and include them in the data model listed above.
Time frame: 6 months
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 31 Jul 2017.
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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.
William Shannon, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Restless Leg Syndrome, run by Washington University School of Medicine at 1 site in United States.
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 4 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 31 Jul 2017. 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 United States. 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. 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?
Define an object oriented data model for actigraphy and patient level data. (time frame: 6 months). 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 31 Jul 2017.