RelaxationRELAXPENCT05546307
Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials
A study testing SSEP and relaxation session in people with Relaxation and Somatosensory Evoked Potentials, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relaxation, Somatosensory Evoked Potentials, Patient Experience
- What is being tested?
- SSEP and relaxation session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient addressed for a study of the somatosensory evoked potentials in upper limbs
- Patients between 18 to 70 years old.
- Patients able to understand the instructions of the relaxation session and the examination.
- Patient providing informed consent exclusion criteria
Who cannot join
- No availability of a technician trained in relaxation
- Patient's refusal to participate in the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, Picardie, 80054
Caroline CARRE, 03 22 08 77 76, carre.caroline@chu-amiens.fr
Philippe-Edouard MERLE, Dr
About this study
Official title: Randomized, Single-blind Study Evaluating the Interest of Prior Relaxation on the Quality of the Recordings of the SomatoSensory Evoked Potentials
Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation.
The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination.
The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience
- Being tested
- SSEP, relaxation session
- Keywords
- Relaxation, Somatosensory Evoked Potentials, Patient experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSEPOther
Every patient presenting for a SSEP will be offered to participate to the study. If accepted, a randomization will determine whether the examination will be preceded by a relaxation session (Relax Group) or not (control group)
relaxation sessionOther
The relaxation session will be performed by one of the 5 nurses trained in relaxation
| Study group | Role | What they receive |
|---|---|---|
| one relaxation session before the examination | Experimental | Not described Receives: Other: SSEP; Other: relaxation session |
| No relaxation session before the examination | Active comparator | Not described Receives: Other: SSEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of average rate of automatized artifacts rejection between both groups
Average rate of automatized artifacts rejection during 2 sessions of 1000 stimulations on the first stimulated limb to obtain the N13 wave
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start15 Sep 2022
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RelaxationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546307
- Sponsor's protocol ID
- PI2019_843_0079
- Acronym
- RELAXPE
- Status last verified
- Jun 2025
- First submitted
- 15 Sep 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind Study Evaluating the Interest of Prior Relaxation on the Quality of the Recordings of the SomatoSensory Evoked Potentials
- ClinicalTrials.gov ID
- NCT05546307
- Acronym / sponsor ID
- RELAXPE / PI2019_843_0079
- Keywords
- Relaxation, Somatosensory Evoked Potentials, Patient experience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Sep 2022 (actual)
- 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.
Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation.
The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination.
The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one relaxation session before the examination | Experimental | Other: SSEP, Other: relaxation session |
| No relaxation session before the examination | Active comparator | Other: SSEP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient addressed for a study of the somatosensory evoked potentials in upper limbs
- Patients between 18 to 70 years old.
- Patients able to understand the instructions of the relaxation session and the examination.
- Patient providing informed consent exclusion criteria
Key exclusion criteria (2 listed)
- No availability of a technician trained in relaxation
- Patient's refusal to participate in the protocol
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 |
|---|---|---|
| SSEPEvery patient presenting for a SSEP will be offered to participate to the study. If accepted, a randomization will determine whether the examination will be preceded by a relaxation session (Relax Group) or not (control group) | Other | No relaxation session before the examination, one relaxation session before the examination |
| relaxation sessionThe relaxation session will be performed by one of the 5 nurses trained in relaxation | Other | one relaxation session before the examination |
Primary outcome
Variation of average rate of automatized artifacts rejection between both groups
Time frame: 19 months
Average rate of automatized artifacts rejection during 2 sessions of 1000 stimulations on the first stimulated limb to obtain the N13 wave
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSEP and relaxation session in people with Relaxation and Somatosensory Evoked Potentials, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 Jun 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline CARRE (03 22 08 77 76, carre.caroline@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of average rate of automatized artifacts rejection between both groups (time frame: 19 months). 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 4 Jun 2025.