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Validation Study for an Unobtrusive Online Sleep Measurement System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633151
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : October 1, 2013
Information provided by (Responsible Party): 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.

Condition or disease
Apnea Restless Legs Syndrome Sleep Fragmentation

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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
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

20 volunteers

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

Inclusion Criteria:

  • Age 18-80
  • Finnish-speaking

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 identifier (NCT number): NCT01633151

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Helsinki Sleep Clinic, Vitalmed Research Centre
Helsinki, Finland, 00420
Sponsors and Collaborators Ltd
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Principal Investigator: Markku Partinen, MD, PhD Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland

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Responsible Party: Ltd Identifier: NCT01633151    
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:
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Restless Legs Syndrome
Sleep Deprivation
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders