Sleep Apnea, ObstructiveLAVIMONCT01626274
Long Term Vital Parameter Monitoring (LAVIMO)
A study testing LAVIMO in- ear sensor system in people with Sleep Apnea, Obstructive, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the feasibility of non-intrusive 24 hours non-invasive measurements with minimized LAVIMO sensor system. The LAVIMO-system is a photoplethysmographic device for reflective mode measurements of the optical damping upper skin layers inside of the ear canal at two different wave… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- LAVIMO in- ear sensor system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Feb 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients > 18 years who routinely have to undergo a polysomnography night
- sleep apnoea patient
- able to give informed consent
Who cannot join
- dementia
- cochlea implant
- severe lung diseases
- allergy against material of the sensor
- inflammation of the middle ear
- inflammation of auditory canal
- occlusion because of cerumen
- electric implants
Trial locations and contacts
1 site in 1 country.
Germany1 site
Neurological Clinic , University Hospital
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Long Term Vital Parameter Monitoring Pilot Study to Evaluate Measurement Data Via In-ear Sensor in Comparison to Standard Polysomnography in Sleep Laboratory
The purpose of this study is to evaluate the feasibility of non-intrusive 24 hours non-invasive measurements with minimized LAVIMO sensor system. The LAVIMO-system is a photoplethysmographic device for reflective mode measurements of the optical damping upper skin layers inside of the ear canal at two different wave lengths. It consists of the in-ear sensor, the electronics and a PC. Vital signs parameter like heart rate, heart rate variability, breathing and arterial blood oxygenation are monitored in patients with sleep apnoea and compared to measurements of standard polysomnography of these patients during one night in the sleep laboratory.
Read the detailed description
In 20 patients who routinely have to undergo a polysomnographic night in sleep laboratory LAVIMO measurements like heart rate, heart rate variability, breathing and arterial blood oxygenation are performed parallel to standard polysomnography measurements and subsequently compared to the data of the standard polysomnography. The LAVIMO sensor system consists of the in- ear sensor, the electronics and a PC; the individually formed sensor is embedded into an ear mould for proper fit inside the ear canal. Inside two LEDs emit light into the adjacent skin at 760 and 905 nm wavelengths. The intensity of the backscattered light is detected by a photo detector. In the electronics, the control signals for the LEDs are provided, as well as the photo detector signal is further processed and A-D converted. The electronics also provide a wireless connection to the PC via bluetooth. Data recording, post processing and displaying are tasks of the PC. The feasibility of non- intrusive 24 hours and non-invasive measurements like heart rate, heart rate variability, breathing and oxygen saturation is proved via this minimized sensor and electronics placed at a suitable place at the body guaranteeing high wearing comfort. This includes a wireless data communication for unrestricted mobility. Subsequently the data are compared to the standard polysomnography data to extract vital signs or for example to recognize possible phases of sleep apnoea. The goal in future refering to preventive medical monitoring will be early detection of risk factors for patient's health and improvement of living conditions.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- LAVIMO in- ear sensor system
- Keywords
- Polysomnography, Long term vital signs monitoring, In-ear sensor system, Photoplethysmographic micro-optic device, High wearing comfort
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAVIMO in- ear sensor systemDevice
Also called Photoplethysmographic microoptic reflective microsensor
Long term vital signs parameters like heart rate, heart rate variability, breathing and oxygen saturation are measured via in- ear sensor system during 1 polysomnographic night
| Study group | Role | What they receive |
|---|---|---|
| Device: in-ear sensor | Experimental | Patients who routinely undergo a polysomnography night (1 night) are monitored via in-ear sensor which will be embedded in the auditory canal. During this night vital signs parameters are monitored, processed and subsequently compared to the polysomnography data. Receives: Device: LAVIMO in- ear sensor system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extraction of vital signs out of measurement data via individually formed in-ear sensor system in comparison to standard polysomnography data in sleep laboratory
during one polysomnographic night in sleep laboratory the patient will receive the LAVIMO in- ear sensor system and vital parameters like heart rate, heart rate variability, breathing and oxygen saturation will be monitored. Subsequently the data will be processed and compared to the standard polysomnographic data
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Schiefer, MD, Principal investigator, Neurological Clinic, University Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626274
- Sponsor's protocol ID
- CTC-A_10-016
- Other IDs
- EK 231/10
- Acronym
- LAVIMO
- Status last verified
- Nov 2013
- First submitted
- 20 Jun 2012
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Vital Parameter Monitoring Pilot Study to Evaluate Measurement Data Via In-ear Sensor in Comparison to Standard Polysomnography in Sleep Laboratory
- ClinicalTrials.gov ID
- NCT01626274
- Acronym / sponsor ID
- LAVIMO / CTC-A_10-016
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Polysomnography, Long term vital signs monitoring, In-ear sensor system, Photoplethysmographic micro-optic device, High wearing comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Jun 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 this study is to evaluate the feasibility of non-intrusive 24 hours non-invasive measurements with minimized LAVIMO sensor system. The LAVIMO-system is a photoplethysmographic device for reflective mode measurements of the optical damping upper skin layers inside of the ear canal at two different wave lengths. It consists of the in-ear sensor, the electronics and a PC. Vital signs parameter like heart rate, heart rate variability, breathing and arterial blood oxygenation are monitored in patients with sleep apnoea and compared to measurements of standard polysomnography of these patients during one night in the sleep laboratory.
Detailed description
In 20 patients who routinely have to undergo a polysomnographic night in sleep laboratory LAVIMO measurements like heart rate, heart rate variability, breathing and arterial blood oxygenation are performed parallel to standard polysomnography measurements and subsequently compared to the data of the standard polysomnography. The LAVIMO sensor system consists of the in- ear sensor, the electronics and a PC; the individually formed sensor is embedded into an ear mould for proper fit inside the ear canal. Inside two LEDs emit light into the adjacent skin at 760 and 905 nm wavelengths. The intensity of the backscattered light is detected by a photo detector. In the electronics, the control signals for the LEDs are provided, as well as the photo detector signal is further processed and A-D converted. The electronics also provide a wireless connection to the PC via bluetooth. Data recording, post processing and displaying are tasks of the PC. The feasibility of non- intrusive 24 hours and non-invasive measurements like heart rate, heart rate variability, breathing and oxygen saturation is proved via this minimized sensor and electronics placed at a suitable place at the body guaranteeing high wearing comfort. This includes a wireless data communication for unrestricted mobility. Subsequently the data are compared to the standard polysomnography data to extract vital signs or for example to recognize possible phases of sleep apnoea. The goal in future refering to preventive medical monitoring will be early detection of risk factors for patient's health and improvement of living conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: in-ear sensor | Experimental | Device: LAVIMO in- ear sensor systemPatients who routinely undergo a polysomnography night (1 night) are monitored via in-ear sensor which will be embedded in the auditory canal. During this night vital signs parameters are monitored, processed and subsequently compared to the polysomnography data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients > 18 years who routinely have to undergo a polysomnography night
- sleep apnoea patient
- able to give informed consent
Key exclusion criteria (8 listed)
- dementia
- cochlea implant
- severe lung diseases
- allergy against material of the sensor
- inflammation of the middle ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAVIMO in- ear sensor systemAlso: Photoplethysmographic microoptic reflective microsensorLong term vital signs parameters like heart rate, heart rate variability, breathing and oxygen saturation are measured via in- ear sensor system during 1 polysomnographic night | Device | Device: in-ear sensor |
Primary outcome
Extraction of vital signs out of measurement data via individually formed in-ear sensor system in comparison to standard polysomnography data in sleep laboratory
Time frame: one night
during one polysomnographic night in sleep laboratory the patient will receive the LAVIMO in- ear sensor system and vital parameters like heart rate, heart rate variability, breathing and oxygen saturation will be monitored. Subsequently the data will be processed and compared to the standard polysomnographic data
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 27 Nov 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.
Johannes Schiefer, MD principal investigator
Neurological Clinic, University Hospital Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAVIMO in- ear sensor system in people with Sleep Apnea, Obstructive, run by RWTH Aachen University at 1 site in Germany.
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 3 inclusion and 8 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 27 Nov 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 Germany. 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?
Extraction of vital signs out of measurement data via individually formed in-ear sensor system in comparison to standard polysomnography data in sleep laboratory (time frame: one night). 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 27 Nov 2013.