Sleep Measurement Study

NCT04288557 | Completed

• 1 other identifier: 0713
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Total sleep time

  minutes

  10 days

Secondary Outcomes (4)

• Time in bed

  10 days

• Sleep efficiency

  10 days

• Sleep onset

  10 days

• Waking time

  10 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• \. 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Leicester Diabetes Centre

Leicester, LE5 4PW, United Kingdom

Location

Study Officials

• Charlotte Edwardson

  University of Leicester

  STUDY DIRECTOR

• Andrew Hall

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 28, 2020
• Study Start: January 23, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-04

Locations

GB (1)