ApneaNCT01633151
Validation Study for an Unobtrusive Online Sleep Measurement System
An observational study of Apnea and Restless Legs Syndrome, run by Beddit.com Ltd at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Apnea, Restless Legs Syndrome, Sleep Fragmentation
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A group of 20 volunteers - 10 males, 10 females - is recruited so that their ages are distributed evenly between 18 and 80.
Who may be able to join
- Age 18-80
- Finnish-speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Apnea, Restless Legs Syndrome, Sleep Fragmentation
- Medical subject headings
- Apnea, Restless Legs Syndrome, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 20 volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beddit.com Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markku Partinen, MD, PhD, Principal investigator, Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633151
- Sponsor's protocol ID
- BEDDIT-2012-1
- Status last verified
- Sep 2013
- First submitted
- 20 Jun 2012
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study for an Unobtrusive Online Sleep Measurement System
- ClinicalTrials.gov ID
- NCT01633151
- Acronym / sponsor ID
- BEDDIT-2012-1
- Conditions
- Apnea, Restless Legs Syndrome, Sleep Fragmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beddit.com LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 volunteers | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A group of 20 volunteers - 10 males, 10 females - is recruited so that their ages are distributed evenly between 18 and 80.
Key inclusion criteria (2 listed)
- Age 18-80
- Finnish-speaking
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markku Partinen, MD, PhD principal investigator
Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea and Restless Legs Syndrome, run by Beddit.com Ltd at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision of sleep measurement (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.