NCT01633151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

1.3 years

First QC Date

June 20, 2012

Last Update Submit

September 29, 2013

Conditions

ApneaRestless Legs SyndromeSleep Fragmentation

Outcome Measures

Primary Outcomes (1)

  • Precision of sleep measurement

    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

Study Arms (1)

20 volunteers

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age 18-80
  • Finnish-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki Sleep Clinic, Vitalmed Research Centre

Helsinki, 00420, Finland

Location

MeSH Terms

Conditions

ApneaRestless Legs SyndromeSleep Deprivation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsNervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental DisordersNeurologic Manifestations

Study Officials

  • Markku Partinen, MD, PhD

    Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

July 4, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

FI(1)