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Validation Study for an Unobtrusive Online Sleep Measurement System

This study is currently recruiting participants.
Verified March 2013 by Beddit.com Ltd
Sponsor:
Information provided by (Responsible Party):
Beddit.com Ltd
ClinicalTrials.gov Identifier:
NCT01633151
First received: June 20, 2012
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Apnea
Restless Legs Syndrome
Sleep Fragmentation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation Study for an Unobtrusive Online Sleep Measurement System

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Further study details as provided by Beddit.com Ltd:

Primary Outcome Measures:
  • Precision of sleep measurement [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
20 volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633151

Contacts
Contact: Joonas Paalasmaa, BSc, MSc +358505820100 joonas.paalasmaa@helsinki.fi

Locations
Finland
Helsinki Sleep Clinic, Vitalmed Research Center Recruiting
Helsinki, Finland, 00420
Contact: Markku Partinen, MD, PhD     +358102311480        
Principal Investigator: Markku Partinen, MD, PhD            
Sponsors and Collaborators
Beddit.com Ltd
Investigators
Principal Investigator: Markku Partinen, MD, PhD Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland
  More Information

No publications provided

Responsible Party: Beddit.com Ltd
ClinicalTrials.gov Identifier: NCT01633151     History of Changes
Other Study ID Numbers: BEDDIT-2012-1
Study First Received: June 20, 2012
Last Updated: March 27, 2013
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013