Obstructive Sleep Apnea SyndromeEKINOxNCT02789748
PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes
A study testing Kinesthetic stimulation in people with Obstructive Sleep Apnea Syndrome, run by LivaNova at 4 sites in France.
Trial summary
This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Kinesthetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jun 2016to 2 Oct 2017
- 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 who meet all the following criteria at the time of enrollment may be included:
- Man or woman aged more than 18 years old.
- Patient with severe obstructive apnea syndrome diagnosed on polysomnography or polygraphy performed less than 6 months ago with (AHI > 30/h and 80% of obstructive events) and (ODI 4% > 20 or time with SaO2 below 90% > 5%).
- Patient free from continuous positive airway pressure (CPAP) treatment or any other SAS treatment for at least 3 months
- Patient with no psychrotropic medication or stable psychotropic medication since the diagnostic polysomnography or polygraphy examination
- Patient was informed and has signed the informed consent
Who cannot join
- Patients who meet any one of these criteria will be excluded from the study:
- Patients sleeping less than 4 hours per night
- Patients suffering from respiratory failure, such as chronic obstructive pulmonary disease (COPD), pneumonia, pulmonary edema, pulmonary fibrosis, asthma, pulmonary arterial hypertension.
- Patients developing periodic breathing or Cheyne Stokes respiration
- Obese patient (BMI>35kg/m2)
- Patient with autonomic dysfunction (symptoms include orthostatic hypotension, exercise intolerance, sweating abnormalities, digestion difficulties, urinary problems, vision problems) as complication of diabetes, Parkinson's disease or other primary pathologies.
Show all 12Show fewer
- Patient suffering from restless leg syndrome or periodic leg movement (PLM) not related to obstructive sleep apnea, i.e. PLM index > 15/h excluding movements linked to respiratory events.
- Patient suffering from positional sleep apnea syndrome (SAS), i.e. supine apnea hypopnea index (AHI) at least twice that of the non-supine AHI
- Patient suffering from severe peripheral neuropathy
- Vulnerable patient in accordance with article L1121-6 of Code de la Santé Publique (CSP)
- Patient already involved in another clinical study that could affect the result of this study
- Pregnant patient
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hospital Beziers
Béziers, 34500
University Hospital Grenoble
Grenoble, 38043
CHU Rennes
Rennes
University Hospital Tours
Tours, 37 044
About this study
This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.
Read the detailed description
Severe sleep apnea patients will undergo two polysomnographies (PSG), one with kinesthetic stimulation triggered on the detection of apneas and hypopneas (treated night ) and the other without kinesthetic stimulation (non-treated night ). Comparison of apnea and hypopnea indices (AHI) and of oxygen saturation between the treated and non-treated night will be taken as indicators to quantify the performance of this potential new therapy.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Kinesthetic stimulation
- 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.
Kinesthetic stimulationDevice
Activation of mechanoreceptors by vibration bursts
| Study group | Role | What they receive |
|---|---|---|
| Treatment ON | Experimental | Kinesthetic stimulation administered during one night Receives: Device: Kinesthetic stimulation |
| Treatment OFF | No intervention | NO kinesthetic stimulation administered during one night |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of responder to the therapy
A patient is defined as 'responder' to the therapy by comparison of the treated night to the non-treated night based on:
- The oxygen desaturation index (ODI)
- The time spent below 90% of oxygen saturation or
- The apnea hypopnea index (AHI) reduction
Measured: Day 1 post-discharge
Secondary outcomes (6)
Adverse device effect
Adverse Events related to the investigational device
Measured: Day 1 post-discharge
Effect on apneas/hypopneas duration
Therapy effect on shortening respiratory events
Measured: Day 1 post-discharge
Effect on modified apnea hypopnea index
The modified apnea hypopnea indices (AHIs) will be compared between the treated and non-treated night and defined based on the duration of the respiratory disorders
Measured: Day 1 post-discharge
Instantaneous heart rate measurement (bpm) during the night ON and the night OFF
Measured: Day 1 post-discharge
Number of arousals per night - comparison night ON and night OFF
The micro-arousal index will be calculated on the polysomnography recording.
Measured: Day 1 post-discharge
Effect on an objective measure of somnolence (Osler)
Osler test (optional) performed after treated night and non-treated night
Measured: Day 1 post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion2 Oct 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789748
- Sponsor's protocol ID
- IAHO03
- Acronym
- EKINOx
- Status last verified
- Oct 2017
- First submitted
- 18 Feb 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes
- ClinicalTrials.gov ID
- NCT02789748
- Acronym / sponsor ID
- EKINOx / IAHO03
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Collaborators
- National Research Agency, France
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 3 Jun 2016 (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.
This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.
Detailed description
Severe sleep apnea patients will undergo two polysomnographies (PSG), one with kinesthetic stimulation triggered on the detection of apneas and hypopneas (treated night ) and the other without kinesthetic stimulation (non-treated night ). Comparison of apnea and hypopnea indices (AHI) and of oxygen saturation between the treated and non-treated night will be taken as indicators to quantify the performance of this potential new therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment ON | Experimental | Device: Kinesthetic stimulationKinesthetic stimulation administered during one night |
| Treatment OFF | No intervention | –NO kinesthetic stimulation administered during one night |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman aged more than 18 years old.
- Patient with severe obstructive apnea syndrome diagnosed on polysomnography or polygraphy performed less than 6 months ago with (AHI > 30/h and 80% of obstructive events) and (ODI 4% > 20 or time with SaO2 below 90% > 5%).
- Patient free from continuous positive airway pressure (CPAP) treatment or any other SAS treatment for at least 3 months
- Patient with no psychrotropic medication or stable psychotropic medication since the diagnostic polysomnography or polygraphy examination
- Patient was informed and has signed the informed consent
Key exclusion criteria (12 listed)
- Patients sleeping less than 4 hours per night
- Patients suffering from respiratory failure, such as chronic obstructive pulmonary disease (COPD), pneumonia, pulmonary edema, pulmonary fibrosis, asthma, pulmonary arterial hypertension.
- Patients developing periodic breathing or Cheyne Stokes respiration
- Obese patient (BMI>35kg/m2)
- Patient with autonomic dysfunction (symptoms include orthostatic hypotension, exercise intolerance, sweating abnormalities, digestion difficulties, urinary problems, vision problems) as complication of diabetes, Parkinson's disease or other primary pathologies.
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 |
|---|---|---|
| Kinesthetic stimulationActivation of mechanoreceptors by vibration bursts | Device | Treatment ON |
Primary outcome
Rate of responder to the therapy
Time frame: Day 1 post-discharge
A patient is defined as 'responder' to the therapy by comparison of the treated night to the non-treated night based on: * The oxygen desaturation index (ODI) * The time spent below 90% of oxygen saturation or * The apnea hypopnea index (AHI) reduction
6 secondary outcomes
Adverse device effect
Time frame: Day 1 post-discharge
Effect on apneas/hypopneas duration
Time frame: Day 1 post-discharge
Effect on modified apnea hypopnea index
Time frame: Day 1 post-discharge
Instantaneous heart rate measurement (bpm) during the night ON and the night OFF
Time frame: Day 1 post-discharge
Number of arousals per night - comparison night ON and night OFF
Time frame: Day 1 post-discharge
Effect on an objective measure of somnolence (Osler)
Time frame: Day 1 post-discharge
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 5 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesthetic stimulation in people with Obstructive Sleep Apnea Syndrome, run by LivaNova at 4 sites in France.
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 6 inclusion and 12 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Rate of responder to the therapy (time frame: Day 1 post-discharge). 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 5 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.