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Validation Study for an Unobtrusive Online Sleep Measurement System

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ClinicalTrials.gov Identifier: NCT01633151
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Apnea Restless Legs Syndrome Sleep Fragmentation

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Validation Study for an Unobtrusive Online Sleep Measurement System
Study Start Date : June 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
20 volunteers


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • Age 18-80
  • Finnish-speaking
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633151


Locations
Finland
Helsinki Sleep Clinic, Vitalmed Research Centre
Helsinki, Finland, 00420
Sponsors and Collaborators
Beddit.com Ltd
Investigators
Principal Investigator: Markku Partinen, MD, PhD Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland
More Information

Responsible Party: Beddit.com Ltd
ClinicalTrials.gov Identifier: NCT01633151     History of Changes
Other Study ID Numbers: BEDDIT-2012-1
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Restless Legs Syndrome
Sleep Deprivation
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Neurologic Manifestations
Signs and Symptoms