Validation Study for an Unobtrusive Online Sleep Measurement System

Completed

• Conditions: Apnea; Restless Legs Syndrome; Sleep Fragmentation

• Registration Number: NCT01633151
• Lead Sponsor: Beddit.com Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-30
• Study First Posted: 2012-07-04
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-29
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 18-80
• Finnish-speaking

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Precision of sleep measurement	7 days	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.

Trial Locations

Locations (1)

Helsinki Sleep Clinic, Vitalmed Research Centre; 🇫🇮 Helsinki, Finland