Sensorineural Hearing LossNCT03212924
Listening Effort in Cochlear Implant Users
A study testing Pupillometry, Evaluation of speech comprehension in quiet and Evaluation of speech comprehension in noise in people with Sensorineural Hearing Loss and Cochlear Hearing Loss, run by Oticon Medical at 1 site in France.
Trial summary
Listening with a cochlear implant remains difficult and most listeners will report high levels of listening effort.The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sensorineural Hearing Loss, Cochlear Hearing Loss
- What is being tested?
- Pupillometry, Evaluation of speech comprehension in quiet and Evaluation of speech comprehension in noise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2017to 27 Mar 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- Native French speaker or fluent French speaker
- Patient already fitted with one or two cochlear implants Oticon Medical
- Can correctly identify at least 10 % of the words in monosyllabic Lafon lists in quiet
- Normal or corrected to normal vision
Who cannot join
- vulnerable patients (kids, pregnant women, persons under guardianship)
- No Social security affiliation
- blindness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Listening Effort With Pupillometry in Cochlear Implant Users
Listening with a cochlear implant remains difficult and most listeners will report high levels of listening effort.The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. The listening effort is measured with pupillometry, by monitoring the variations of pupil size in response to different stimuli. The size of the pupil is known to increase with the listening effort. The listening effort is evaluated in two different situation: speech perception in quiet and speech perception in noise. The pupillometry measures will be compared for the two listening conditions. Moreover, the study will evaluate the relationship between objective (pupil dilatation) and subjective measures (auto evaluation) of listening effort, and between speech comprehension, cognitive abilities and listening effort.
Read the detailed description
Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Most CI users can understand speech in quiet, but comprehension scores drop in the presence of background noise and in adverse conditions. Listening with a cochlear implant remains very demanding and most listeners report high levels of listening effort. The aim of current auditory prostheses and cochlear implants is not only restore speech understanding, but also to restore all the cognitive functions that are associated to a listening task (e.g., memory, executive functions, attention). Evaluating the listening effort is a new way to assess the efficiency of the hearing aids or cochlear implants. The listening effort indicates the amount of cognitive resources that are dedicated to a listening task; it evaluates also the cognitive resources remaining available for the other cognitive functions. The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. The listening effort is measured with pupillometry, i. e. by measuring the pupil dilatation in response to different stimuli. The size of the pupil is known to increase with the listening effort. The listening effort is evaluated in two different situation: speech perception in quiet and speech perception in noise. Speech comprehension is measured for the two listening conditions and cognitive functions are assessed by the MOCA (Montreal Cognitive Assessment). In addition, the subjects are asked to subjectively evaluate the amount of listening effort they used in each listening situation. The pupillometry measures will be compared for the two listening conditions. Moreover, the study will evaluate the relationship between objective (pupil dilatation) and subjective measures (self evaluation) of listening effort, and between speech comprehension, cognitive abilities and listening effort.
- Conditions
- Sensorineural Hearing Loss, Cochlear Hearing Loss
- Being tested
- Pupillometry, Evaluation of speech comprehension in quiet, Evaluation of speech comprehension in noise, MOCA, auto evaluation of listening effort in quiet
- Keywords
- cochlear implant, Listening effort, pupillometry
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillometryBehavioural
Measure of pupil dilatation simultaneously to the evaluation of speech intelligibility. The variation of the pupil size is monitored during the presentation of speech stimuli in quiet and in the presence of a background noise.
Evaluation of speech comprehension in quietBehavioural
Three lists of 17 monosyllabic words (Lafon) are presented in quiet at 65 dB SPL. Listeners have to repeat what they understood. The results correspond to the percent of phonemes correctly identified.
Evaluation of speech comprehension in noiseBehavioural
Three lists of 17 monosyllabic words (Lafon) are presented in a wide band noise at 65 dB SPL with a SNR (signal to noise ratio) of +10 dB. Listeners have to repeat what they understood. The results correspond to the percent of phonemes correctly identified.
MOCABehavioural
Also called Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a screening instrument to detect cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points. The test suggests the existence of a cognitive impairment if the participant scores less than 26 points. The test is presented on a single sheet of paper.
auto evaluation of listening effort in quietBehavioural
Also called VAS (visual analog scale) in quiet
The participant has to represent, on a continuous line, the amount of listening effort he used when listening to the monosyllabic words presented in quiet. A score from 0 (no listening effort) to 10 (effort maximum) is extracted from his response.
auto evaluation of listening effort in noiseBehavioural
Also called VAS (visual analog scale) in noise
The participant has to represent, on a continuous line, the amount of listening effort he used when listening to the monosyllabic words presented in the background noise. A score from 0 (no listening effort) to 10 (effort maximum) is extracted from his response.
| Study group | Role | What they receive |
|---|---|---|
| Pupillometry | Experimental | Measure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise.
Evaluation of speech comprehension in quiet
Evaluation of speech comprehension in noise
Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment)
Auto evaluation of listening effort in quiet
Auto evaluation of listening effort in noise Receives: Behavioral: Pupillometry; Behavioral: Evaluation of speech comprehension in quiet; Behavioral: Evaluation of speech comprehension in noise; Behavioral: MOCA; Behavioral: auto evaluation of listening effort in quiet; Behavioral: auto evaluation of listening effort in noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil dilatation (mm)
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. Measures of pupil dilatation are compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Measured: 1 hour
Amplitude of peak of pupil dilatation
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The amplitude of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Measured: 1 hour
Latency of peak of pupil dilatation (ms)
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The latency of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Measured: 1 hour
Secondary outcomes (5)
Speech intelligibility in quiet
percentage of phonemes correctly identify when the speech stimuli (monosyllabic words of Lafon) are presented in quiet at 65 dB SPL
Measured: 30 mins simultaneously to pupillometry measures
Speech intelligibility in noise
percentage of phonemes correctly identify when the speech stimuli (monosyllabic words of Lafon) are presented in a wide band noise at 65 dB SPL with a +10 dB SNR (signal to noise ratio)
Measured: 30 mins simultaneously to pupillometry measures
MOCA (Montreal Cognitive assessment)
Score at the MOCA. The maximum score is 30. The test suggests the existence of a cognitive impairment if the score is lower than 26.
Measured: 15 mins
VAS quiet
Auto evaluation of the listening effort in quiet with Visual Analog Scale. The participant has to indicate, on a continuous line, the listening effort used in the quiet condition. A score from 0 (no effort) to 10 (maximum effort) is extracted from the VAS.
Measured: 1 min
VAS noise
Auto evaluation of the listening effort in quiet with Visual Analog Scale. The participant has to indicate, on a continuous line, the listening effort used in the noise condition. A score from 0 (no effort) to 10 (maximum effort) is extracted from the VAS.
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start19 Sep 2017
- Primary completion27 Mar 2018
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing LossStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle Mosnier, MD, Principal investigator, Hôpital Pitié Sapêtrière - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212924
- Sponsor's protocol ID
- PIC_13
- Status last verified
- Aug 2018
- First submitted
- 6 Jul 2017
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kramer SE, Teunissen CE, Zekveld AA. Cortisol, Chromogranin A, and Pupillary Responses Evoked by Speech Recognition Tasks in Normally Hearing and Hard-of-Hearing Listeners: A Pilot Study. Ear Hear. 2016 Jul-Aug;37 Suppl 1:126S-35S. doi: 10.1097/AUD.0000000000000311.
PubMed 27355762Steel MM, Papsin BC, Gordon KA. Binaural fusion and listening effort in children who use bilateral cochlear implants: a psychoacoustic and pupillometric study. PLoS One. 2015 Feb 10;10(2):e0117611. doi: 10.1371/journal.pone.0117611. eCollection 2015.
PubMed 25668423Winn MB, Edwards JR, Litovsky RY. The Impact of Auditory Spectral Resolution on Listening Effort Revealed by Pupil Dilation. Ear Hear. 2015 Jul-Aug;36(4):e153-65. doi: 10.1097/AUD.0000000000000145.
PubMed 25654299Koelewijn T, Zekveld AA, Festen JM, Kramer SE. Pupil dilation uncovers extra listening effort in the presence of a single-talker masker. Ear Hear. 2012 Mar-Apr;33(2):291-300. doi: 10.1097/AUD.0b013e3182310019.
PubMed 21921797Zekveld AA, Kramer SE. Cognitive processing load across a wide range of listening conditions: insights from pupillometry. Psychophysiology. 2014 Mar;51(3):277-84. doi: 10.1111/psyp.12151. Epub 2014 Feb 9.
PubMed 24506437Zekveld AA, Heslenfeld DJ, Johnsrude IS, Versfeld NJ, Kramer SE. The eye as a window to the listening brain: neural correlates of pupil size as a measure of cognitive listening load. Neuroimage. 2014 Nov 1;101:76-86. doi: 10.1016/j.neuroimage.2014.06.069. Epub 2014 Jul 3.
PubMed 24999040Zekveld AA, Kramer SE, Festen JM. Cognitive load during speech perception in noise: the influence of age, hearing loss, and cognition on the pupil response. Ear Hear. 2011 Jul-Aug;32(4):498-510. doi: 10.1097/AUD.0b013e31820512bb.
PubMed 21233711Zekveld AA, Kramer SE, Festen JM. Pupil response as an indication of effortful listening: the influence of sentence intelligibility. Ear Hear. 2010 Aug;31(4):480-90. doi: 10.1097/AUD.0b013e3181d4f251.
PubMed 20588118Pals C, Sarampalis A, Baskent D. Listening effort with cochlear implant simulations. J Speech Lang Hear Res. 2013 Aug;56(4):1075-84. doi: 10.1044/1092-4388(2012/12-0074). Epub 2012 Dec 28.
PubMed 23275424
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Listening Effort With Pupillometry in Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT03212924
- Acronym / sponsor ID
- PIC_13
- Conditions
- Sensorineural Hearing Loss, Cochlear Hearing Loss
- Keywords
- cochlear implant, Listening effort, pupillometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 11 Jul 2017 (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.
Listening with a cochlear implant remains difficult and most listeners will report high levels of listening effort.The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. The listening effort is measured with pupillometry, by monitoring the variations of pupil size in response to different stimuli. The size of the pupil is known to increase with the listening effort. The listening effort is evaluated in two different situation: speech perception in quiet and speech perception in noise. The pupillometry measures will be compared for the two listening conditions. Moreover, the study will evaluate the relationship between objective (pupil dilatation) and subjective measures (auto evaluation) of listening effort, and between speech comprehension, cognitive abilities and listening effort.
Detailed description
Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Most CI users can understand speech in quiet, but comprehension scores drop in the presence of background noise and in adverse conditions. Listening with a cochlear implant remains very demanding and most listeners report high levels of listening effort. The aim of current auditory prostheses and cochlear implants is not only restore speech understanding, but also to restore all the cognitive functions that are associated to a listening task (e.g., memory, executive functions, attention). Evaluating the listening effort is a new way to assess the efficiency of the hearing aids or cochlear implants. The listening effort indicates the amount of cognitive resources that are dedicated to a listening task; it evaluates also the cognitive resources remaining available for the other cognitive functions. The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. The listening effort is measured with pupillometry, i. e. by measuring the pupil dilatation in response to different stimuli. The size of the pupil is known to increase with the listening effort. The listening effort is evaluated in two different situation: speech perception in quiet and speech perception in noise. Speech comprehension is measured for the two listening conditions and cognitive functions are assessed by the MOCA (Montreal Cognitive Assessment). In addition, the subjects are asked to subjectively evaluate the amount of listening effort they used in each listening situation. The pupillometry measures will be compared for the two listening conditions. Moreover, the study will evaluate the relationship between objective (pupil dilatation) and subjective measures (self evaluation) of listening effort, and between speech comprehension, cognitive abilities and listening effort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pupillometry | Experimental | Behavioral: Pupillometry, Behavioral: Evaluation of speech comprehension in quiet, Behavioral: Evaluation of speech comprehension in noise, Behavioral: MOCA, Behavioral: auto evaluation of listening effort in quiet, Behavioral: auto evaluation of listening effort in noiseMeasure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise. Evaluation of speech comprehension in quiet Evaluation of speech comprehension in noise Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment) Auto evaluation of listening effort in quiet Auto evaluation of listening effort in noise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- informed consent
- Native French speaker or fluent French speaker
- Patient already fitted with one or two cochlear implants Oticon Medical
- Can correctly identify at least 10 % of the words in monosyllabic Lafon lists in quiet
- Normal or corrected to normal vision
Key exclusion criteria (3 listed)
- vulnerable patients (kids, pregnant women, persons under guardianship)
- No Social security affiliation
- blindness
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 |
|---|---|---|
| PupillometryMeasure of pupil dilatation simultaneously to the evaluation of speech intelligibility. The variation of the pupil size is monitored during the presentation of speech stimuli in quiet and in the presence of a background noise. | Behavioural | Pupillometry |
| Evaluation of speech comprehension in quietThree lists of 17 monosyllabic words (Lafon) are presented in quiet at 65 dB SPL. Listeners have to repeat what they understood. The results correspond to the percent of phonemes correctly identified. | Behavioural | Pupillometry |
| Evaluation of speech comprehension in noiseThree lists of 17 monosyllabic words (Lafon) are presented in a wide band noise at 65 dB SPL with a SNR (signal to noise ratio) of +10 dB. Listeners have to repeat what they understood. The results correspond to the percent of phonemes correctly identified. | Behavioural | Pupillometry |
| MOCAAlso: Montreal Cognitive AssessmentThe Montreal Cognitive Assessment (MoCA) is a screening instrument to detect cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points. The test suggests the existence of a cognitive impairment if the participant scores less than 26 points. The test is presented on a single sheet of paper. | Behavioural | Pupillometry |
| auto evaluation of listening effort in quietAlso: VAS (visual analog scale) in quietThe participant has to represent, on a continuous line, the amount of listening effort he used when listening to the monosyllabic words presented in quiet. A score from 0 (no listening effort) to 10 (effort maximum) is extracted from his response. | Behavioural | Pupillometry |
| auto evaluation of listening effort in noiseAlso: VAS (visual analog scale) in noiseThe participant has to represent, on a continuous line, the amount of listening effort he used when listening to the monosyllabic words presented in the background noise. A score from 0 (no listening effort) to 10 (effort maximum) is extracted from his response. | Behavioural | Pupillometry |
Primary outcome
Pupil dilatation (mm)
Time frame: 1 hour
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. Measures of pupil dilatation are compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Amplitude of peak of pupil dilatation
Time frame: 1 hour
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The amplitude of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
Latency of peak of pupil dilatation (ms)
Time frame: 1 hour
The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The latency of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).
5 secondary outcomes
Speech intelligibility in quiet
Time frame: 30 mins simultaneously to pupillometry measures
Speech intelligibility in noise
Time frame: 30 mins simultaneously to pupillometry measures
MOCA (Montreal Cognitive assessment)
Time frame: 15 mins
VAS quiet
Time frame: 1 min
VAS noise
Time frame: 1 min
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 22 Aug 2018.
- Results publication: PubMed 27355762Kramer SE, Teunissen CE, Zekveld AA. Cortisol, Chromogranin A, and Pupillary Responses Evoked by Speech Recognition Tasks in Normally Hearing and Hard-of-Hearing Listeners: A Pilot Study. Ear Hear. 2016 Jul-Aug;37 Suppl 1:126S-35S. doi: 10.1097/AUD.0000000000000311.
- Results publication: PubMed 25668423Steel MM, Papsin BC, Gordon KA. Binaural fusion and listening effort in children who use bilateral cochlear implants: a psychoacoustic and pupillometric study. PLoS One. 2015 Feb 10;10(2):e0117611. doi: 10.1371/journal.pone.0117611. eCollection 2015.
- Results publication: PubMed 25654299Winn MB, Edwards JR, Litovsky RY. The Impact of Auditory Spectral Resolution on Listening Effort Revealed by Pupil Dilation. Ear Hear. 2015 Jul-Aug;36(4):e153-65. doi: 10.1097/AUD.0000000000000145.
- Results publication: PubMed 21921797Koelewijn T, Zekveld AA, Festen JM, Kramer SE. Pupil dilation uncovers extra listening effort in the presence of a single-talker masker. Ear Hear. 2012 Mar-Apr;33(2):291-300. doi: 10.1097/AUD.0b013e3182310019.
- Results publication: PubMed 24506437Zekveld AA, Kramer SE. Cognitive processing load across a wide range of listening conditions: insights from pupillometry. Psychophysiology. 2014 Mar;51(3):277-84. doi: 10.1111/psyp.12151. Epub 2014 Feb 9.
- Results publication: PubMed 24999040Zekveld AA, Heslenfeld DJ, Johnsrude IS, Versfeld NJ, Kramer SE. The eye as a window to the listening brain: neural correlates of pupil size as a measure of cognitive listening load. Neuroimage. 2014 Nov 1;101:76-86. doi: 10.1016/j.neuroimage.2014.06.069. Epub 2014 Jul 3.
- Results publication: PubMed 21233711Zekveld AA, Kramer SE, Festen JM. Cognitive load during speech perception in noise: the influence of age, hearing loss, and cognition on the pupil response. Ear Hear. 2011 Jul-Aug;32(4):498-510. doi: 10.1097/AUD.0b013e31820512bb.
- Results publication: PubMed 20588118Zekveld AA, Kramer SE, Festen JM. Pupil response as an indication of effortful listening: the influence of sentence intelligibility. Ear Hear. 2010 Aug;31(4):480-90. doi: 10.1097/AUD.0b013e3181d4f251.
- Results publication: PubMed 23275424Pals C, Sarampalis A, Baskent D. Listening effort with cochlear implant simulations. J Speech Lang Hear Res. 2013 Aug;56(4):1075-84. doi: 10.1044/1092-4388(2012/12-0074). Epub 2012 Dec 28.
- 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. This study is not recruiting at the moment.
Isabelle Mosnier, MD principal investigator
Hôpital Pitié Sapêtrière - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupillometry, Evaluation of speech comprehension in quiet and Evaluation of speech comprehension in noise in people with Sensorineural Hearing Loss and Cochlear Hearing Loss, run by Oticon Medical 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 5 inclusion and 3 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 22 Aug 2018. 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?
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?
Pupil dilatation (mm) (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 NCT03212924, which also lists 9 linked publications.
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 22 Aug 2018.