- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288557
Sleep Measurement Study
Validation of Automated Sleep Algorithms for Accelerometer Data in a Clinical and Healthy Adult Population: Sleep Measurement Study
Study Overview
Status
Conditions
Detailed Description
Sleep behaviour has critical importance to health and wellbeing. Insufficient sleep duration and poor sleep quality are independent contributors to high blood pressure and cardiovascular disease, depression, obesity and diabetes. Given the importance of sleep duration and quality to health, the importance of accurately monitoring sleep duration and quality in everyday clinical practice is becoming more evident.
The 'gold standard' physiological measure of sleep is sleep polysomnography (PSG). PSG is used to quantify measures of sleep, including length of sleep, time taken to fall asleep, sleep efficiency. The disadvantages of sleep PSG include the need to attend a laboratory, use of expensive equipment, specialised staff to administer PSG, and to score and interpret the PSG outputs, which limit its use in larger, or free-living studies.
Another method to quantify indices of sleep is based on actigraphy, demonstrating 90% agreement with polysomnography. Wrist actigraphy allows sleep assessment over several days and measures daily sleep-wake cycles. However, the data is in the form of manufacturer-specific activity 'counts' over a specific time window, making it difficult to compare the data with different accelerometer brands. Recently wrist-worn accelerometers have become increasingly used for objective measurement of physical activity in large population studies where participants are often asked to wear them for 24 hours continuously, to maximise compliance. These devices therefore collect data that could be used to estimate sleep parameters, however to be able to use, pool or compare these data there is a need for sleep algorithms that can be applied to datasets from different accelerometer brands. The latest generation of accelerometers measure acceleration in universal units improving comparability among different brands of accelerometers and allowing more control in the data processing. Moreover, now there is a sleep detection algorithm that can applied to data from different raw-data accelerometer brands and is freely available as a part of GGIR package in R (software environment for statistical computing and graphics). The three widely used raw-data accelerometer brands are the Axivity, ActiGraph and GENEActiv and ActivPAL which is a thigh-worn accelerometer that provides a measure of posture using proprietary algorithms; however, raw data are now available.
Studies that have validated the accelerometers with the PSG produced mixed results which can be attributed to use of manufacturer specific sleep algorithms and different accelerometer placement (dominant vs. non-dominant wrist vs. hip). Therefore validation of a sleep algorithm that can be applied to different accelerometer brands against PSG warrants investigation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leicester, United Kingdom, LE5 4PW
- Leicester Diabetes Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Clinical population:
- Participants willing and able to give informed consent for participation in the study
- Male or Female
- Aged 18-65 years inclusive
- Patients on the waiting list for overnight PSG recording at Leicester General Hospital Healthy volunteers
1. Participants willing and able to give informed consent for participation in the study 2. Male or Female 3. Aged 18-65 years inclusive 4. No known sleep disorder (This will be self-reported by the participants)
Exclusion Criteria:
- Participant is unwilling or unable to give informed consent
- Anyone without a good command of the English language
- Anyone <18 years of age and >65 years of age
- Patients suspected of having a movement disorder in sleep (e.g. Periodic Limb Movement in Sleep or REM-Sleep Behaviour Disorder).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Sleep clinic patients
All adult patients, from 18 years and up to and including 65 years of age, on the waiting list for overnight polysomnography (PSG) recording at Leicester General Hospital.
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Healthy volunteers
All adults, from 18 and up to and including 65 years of age without a known sleep disorder.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total sleep time
Time Frame: 10 days
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minutes
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10 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time in bed
Time Frame: 10 days
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minutes
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10 days
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Sleep efficiency
Time Frame: 10 days
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percentage
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10 days
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Sleep onset
Time Frame: 10 days
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hours
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10 days
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Waking time
Time Frame: 10 days
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hours
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10 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Charlotte Edwardson, University of Leicester
- Principal Investigator: Andrew Hall, University Hospitals, Leicester
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0713
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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