Sleep Measurement Study

April 29, 2021 updated by: University of Leicester

Validation of Automated Sleep Algorithms for Accelerometer Data in a Clinical and Healthy Adult Population: Sleep Measurement Study

Sleep behaviour has critical importance to health and wellbeing. A large body of evidence has implicated poor sleep in all-cause mortality, and in cardiovascular and cardiometabolic risk factors. Given the importance of sleep to health, the importance of accurately monitoring sleep duration and quality is becoming more evident. Polysomnography (PSG) is considered the gold standard for sleep assessment. Nevertheless, PSG is impractical, expensive and labour-intensive. Another method to quantify indices of sleep is based on actigraphic measures. Wrist worn actigraphy devices provide an indirect measure of sleep parameters e.g. total sleep time, sleep onset latency and waking time. However, the data is in the form of manufacturer-specific activity 'counts', 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. These devices therefore collect data that could be used to estimate sleep parameters, and now there is a sleep algorithm that can be applied to raw data from accelerometers. 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. Studies that examined accuracy of estimating sleep parameters from different brands of accelerometers compared to PSG have reported conflicting results which could be due to the use of different sleep algorithms and accelerometer placement (dominant vs. non-dominant wrist vs. hip). Therefore this study will aim to validate automated sleep algorithms for research grade accelerometers against PSG in a clinical and healthy adult population.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leicester, United Kingdom, LE5 4PW
        • Leicester Diabetes Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical population: Patients on the waiting list for overnight PSG recording at Leicester General Hospital aged 18-65 Healthy volunteers: adults without known sleep disorder aged 18-65

Description

Inclusion Criteria:

Clinical population:

  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. 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:

  1. Participant is unwilling or unable to give informed consent
  2. Anyone without a good command of the English language
  3. Anyone <18 years of age and >65 years of age
  4. Patients suspected of having a movement disorder in sleep (e.g. Periodic Limb Movement in Sleep or REM-Sleep Behaviour Disorder).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
Healthy volunteers
All adults, from 18 and up to and including 65 years of age without a known sleep disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sleep time
Time Frame: 10 days
minutes
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in bed
Time Frame: 10 days
minutes
10 days
Sleep efficiency
Time Frame: 10 days
percentage
10 days
Sleep onset
Time Frame: 10 days
hours
10 days
Waking time
Time Frame: 10 days
hours
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Charlotte Edwardson, University of Leicester
  • Principal Investigator: Andrew Hall, University Hospitals, Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 23, 2020

Primary Completion (ACTUAL)

February 28, 2021

Study Completion (ACTUAL)

February 28, 2021

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (ACTUAL)

February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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