Validation Study for an Unobtrusive Online Sleep Measurement System

September 29, 2013 updated by: Beddit.com Ltd
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

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

  • Finland
      • Helsinki, Finland, 00420
        • Helsinki Sleep Clinic, Vitalmed Research 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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A group of 20 volunteers - 10 males, 10 females - is recruited so that their ages are distributed evenly between 18 and 80.

Description

Inclusion Criteria:

  • Age 18-80
  • Finnish-speaking

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
20 volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precision of sleep measurement
Time Frame: 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.
7 days

Collaborators and Investigators

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

Sponsor

Beddit.com Ltd

Investigators

  • Principal Investigator: Markku Partinen, MD, PhD, Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland

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

June 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 30, 2012

First Posted (Estimate)

July 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 29, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEDDIT-2012-1

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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