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NCT01633151 Clinical Trial

Validation Study for an Unobtrusive Online Sleep Measurement System

Restless Legs Syndrome Clinical Trial

Official title:
Validation Study for an Unobtrusive Online Sleep Measurement System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01633151
Other study ID # BEDDIT-2012-1
Secondary ID
Status Completed
Phase N/A
First received June 20, 2012
Last updated September 29, 2013
Start date June 2012
Est. completion date September 2013

Study information
Verified date September 2013
Source Beddit.com Ltd
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of the study is to determine the precision of an unobtrusive sleep measurement system. The system measures a force sensor signal under the mattress and analyzes sleep quality. The system measures: time in bed, sleep stages, sleep fragmentation, heart rate, respiration rate, sleep related breathing disorders, and limb movements.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Age 18-80

- Finnish-speaking

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Finland Helsinki Sleep Clinic, Vitalmed Research Centre Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Beddit.com Ltd

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Precision of sleep measurement The volunteers are measured for seven consecutive days. The precision of the sleep measurements output by the ubobtrusive sleep monitoring system is evaluated by comparing the measurements to polysomnography and actigraphy reference measurements. 7 days No
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