Auditory Brainstem ResponsePhase 3NCT03530371
Intranasal Dexmedetomidine for Sedated Hearing Testing
A Phase 3 study testing Dexmedetomidine Hydrochloride in people with Auditory Brainstem Response, run by Fondation Lenval at 1 site in France.
Trial summary
Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles. This test needs a perfect immobility of the child, ideally being asleep. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Auditory Brainstem Response
- What is being tested?
- Dexmedetomidine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2019to 31 Dec 2021
- Phase
- Phase 3
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child aged 1 to 15 years old
- American Society Anesthesiologists (ASA) scale patient 1 or 2
- Need to evaluate the child audition in a context of suspicion of deafness, delay of language, global delay of the development, the risk factors of hearing loss
- Impossibility to realize a hearing test by conventional audiogram or behavioral due to a cognitive or behavioral disorder of the child
- Affiliation to social security scheme
- Signature of the authorization documents of the 2 parents or the representative of the parental authority for the participation of the child in the study
Who cannot join
- Heart disease or heart rhythm disorder
- Pneumopathy or asthmatic crisis in previous 2 weeks in the examination
- Recent used of digoxine or beta-blocker
- Use of anti-epileptic or psychotropic drugs
- Medical history of sleep apnea
- Receptor alpha2 agonist allergy
Show all 13Show fewer
- Gastrooesophageal reflux disease
- Upper airway abnormality
- Acute cerebrovascular diseases
- Neurologic disorders ( cranial trauma and after neurosurgical operation)
- Recent cerebral vascular accident
- Moyamoya disease
- General anesthesia planned for another procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Intranasal Dexmedetomidine for Sedated Auditory Brainstem Response Testing
Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles.
This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children.
Read more
Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients.
The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization.
Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The possibility of an intranasal administration, avoids the pain and discomfort of a venous access insertion.
Read the detailed description
Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles.
This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children.
Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients.
The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization. An intranasal administration avoids the pain and discomfort of a venous access insertion.
Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The treatment will be administrated by intranasal way at a dosage of 2,5µg/ kg in a single administration under continuous cardiorespiratory monitoring for 2 hours..
The objective of this work is to evaluate the effectiveness of intranasal dexmedetomidine in the realization of the auditory brainstem response at the child with a cognitive or behavioral disorder
This study will consist of research involving non-randomized, monocentric prospective interventional for a duration of 30 months. Patients from 1 year of age and under 16 years, in context of suspicion of deafness will be included. In view of active queue of otorhinolaryngology service of Nice University Hospital and taking into account lost sight, the investigators can include 60 patients, to have a representative sample of concerned pediatric population.
The primary endpoint will be the rate of children included in the study who could determine the auditory threshold. The non-determination of this threshold (or the determination by resorting to general anesthesia or sedation of another type) regardless of the cause will be considered a failure.
Despite the lack of specific protocols, the applications of dexmedetomidine in children for many diagnostic procedures have been studied in the past few years.
Any prospective study about the efficacy of dexmedetomidine for auditory brainstem response testing has been yet conducted in children
- Conditions
- Auditory Brainstem Response
- Being tested
- Dexmedetomidine Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
Also called sedated auditory brainstem response
intranasal administration of 2.5µg/kg of dexmedetomidine to fall asleep the patients
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Hydrochloride | Experimental | sedation of patients to perform auditory test Receives: Drug: Dexmedetomidine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of diagnostic
measure the rate of children for who the auditory threshold is obtained with drug sedation condition.
Measured: 5 minutes after the realization of auditory test
Secondary outcomes (3)
tolerance of treatment
The tolerance will measure by the collection of the following undesirable effects:
- hypotension, bradycardia: deviation of> 20% (systolic pressure for blood pressure) from the normal values defined for the age of the subject under waking conditions
- hypertension: deviation of> 20% (systolic pressure for blood pressure) from the normal values defined for the age of the subject in waking conditions
- decrease in oxygenation: decrease in oxygen saturation <90%
These effects will determinate by cardiorespiratory monitoring during the examination. A routine home phone call on D1 will collect information about possible unexpected side effects.
Measured: from drug administration to 24 hours after administration of drug
time of correct sedation
measure of time in minutes between the administration of the drug and the obtaining of a correct sedation (4, 5 or 6 of the score of Ramsey).
Measured: from 5 minutes after drug administration to 5 minutes before auditory test
time of vigilance recovery
measure the time between the end of the examination, (defined by the end of the recording and the disconnection of the electrodes) and the recovery of the vigilance of the child , evaluated by the Aldrete score . A score of 9 or more determines a correct recovery of alertness and the possibility of returning home. The child will be reevaluated every 10 minutes until this score is reached.
Measured: from 5 minutes after auditory test to 5 minutes after the patient wake up (Aldrete score equal to 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start2 May 2019
- Primary completion16 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Auditory Brainstem ResponseStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana GIORDANO, MD, Principal investigator, Hôpitaux Pédiatriques de Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530371
- Sponsor's protocol ID
- 17-HPNCL-02
- Status last verified
- Mar 2023
- First submitted
- 4 May 2018
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giordano A, Lehner B, Voicu A, Donzeau D, Joulie A, Froissant L, Fontas E, Bailleux S. Intranasal dexmedetomidine for sedation in ABR testing in children: No pain, big gain! Int J Pediatr Otorhinolaryngol. 2024 Jun;181:111981. doi: 10.1016/j.ijporl.2024.111981. Epub 2024 May 11.
PubMed 38749259
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intranasal Dexmedetomidine for Sedated Auditory Brainstem Response Testing
- ClinicalTrials.gov ID
- NCT03530371
- Acronym / sponsor ID
- 17-HPNCL-02
- Conditions
- Auditory Brainstem Response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 May 2018 (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.
Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles.
This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children.
Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients.
The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization.
Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The possibility of an intranasal administration, avoids the pain and discomfort of a venous access insertion.
Detailed description
Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles.
This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children.
Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients.
The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization. An intranasal administration avoids the pain and discomfort of a venous access insertion.
Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The treatment will be administrated by intranasal way at a dosage of 2,5µg/ kg in a single administration under continuous cardiorespiratory monitoring for 2 hours..
The objective of this work is to evaluate the effectiveness of intranasal dexmedetomidine in the realization of the auditory brainstem response at the child with a cognitive or behavioral disorder
This study will consist of research involving non-randomized, monocentric prospective interventional for a duration of 30 months. Patients from 1 year of age and under 16 years, in context of suspicion of deafness will be included. In view of active queue of otorhinolaryngology service of Nice University Hospital and taking into account lost sight, the investigators can include 60 patients, to have a representative sample of concerned pediatric population.
The primary endpoint will be the rate of children included in the study who could determine the auditory threshold. The non-determination of this threshold (or the determination by resorting to general anesthesia or sedation of another type) regardless of the cause will be considered a failure.
Despite the lack of specific protocols, the applications of dexmedetomidine in children for many diagnostic procedures have been studied in the past few years.
Any prospective study about the efficacy of dexmedetomidine for auditory brainstem response testing has been yet conducted in children
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Hydrochloride | Experimental | Drug: Dexmedetomidine Hydrochloridesedation of patients to perform auditory test |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child aged 1 to 15 years old
- American Society Anesthesiologists (ASA) scale patient 1 or 2
- Need to evaluate the child audition in a context of suspicion of deafness, delay of language, global delay of the development, the risk factors of hearing loss
- Impossibility to realize a hearing test by conventional audiogram or behavioral due to a cognitive or behavioral disorder of the child
- Affiliation to social security scheme
Key exclusion criteria (13 listed)
- Heart disease or heart rhythm disorder
- Pneumopathy or asthmatic crisis in previous 2 weeks in the examination
- Recent used of digoxine or beta-blocker
- Use of anti-epileptic or psychotropic drugs
- Medical history of sleep apnea
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 |
|---|---|---|
| Dexmedetomidine HydrochlorideAlso: sedated auditory brainstem responseintranasal administration of 2.5µg/kg of dexmedetomidine to fall asleep the patients | Drug | Dexmedetomidine Hydrochloride |
Primary outcome
quality of diagnostic
Time frame: 5 minutes after the realization of auditory test
measure the rate of children for who the auditory threshold is obtained with drug sedation condition.
3 secondary outcomes
tolerance of treatment
Time frame: from drug administration to 24 hours after administration of drug
time of correct sedation
Time frame: from 5 minutes after drug administration to 5 minutes before auditory test
time of vigilance recovery
Time frame: from 5 minutes after auditory test to 5 minutes after the patient wake up (Aldrete score equal to 9)
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 17 Mar 2023.
- Derived from this study: PubMed 38749259Giordano A, Lehner B, Voicu A, Donzeau D, Joulie A, Froissant L, Fontas E, Bailleux S. Intranasal dexmedetomidine for sedation in ABR testing in children: No pain, big gain! Int J Pediatr Otorhinolaryngol. 2024 Jun;181:111981. doi: 10.1016/j.ijporl.2024.111981. Epub 2024 May 11.
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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.
Ana GIORDANO, MD principal investigator
Hôpitaux Pédiatriques de Nice CHU-LENVAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine Hydrochloride in people with Auditory Brainstem Response, run by Fondation Lenval 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 6 inclusion and 13 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 17 Mar 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
quality of diagnostic (time frame: 5 minutes after the realization of auditory test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03530371, which also lists 1 linked publication.
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 17 Mar 2023.