Validation Study for an Unobtrusive Online Sleep Measurement System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beddit.com Ltd
ClinicalTrials.gov Identifier:
NCT01633151
First received: June 20, 2012
Last updated: September 29, 2013
Last verified: September 2013
  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:


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.


Enrollment: 20
Study Start Date: June 2012
Study Completion Date: September 2013
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: September 29, 2013
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Restless Legs Syndrome
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders

ClinicalTrials.gov processed this record on October 16, 2014