SchizophreniaAUDISCHIZNCT02887794
Basic Auditory Processing and Auditory Hallucinations
A study testing Clinical and psychoacoustic measures in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the population worldwide. Although pathophysiology of this disease remains unclear, a growing interest is emerging for low-level sensory function, acknowledging that deficits in early stages of sensory processing are related to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Clinical and psychoacoustic measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2016to 31 Jul 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years old
- Meeting DSM-5.0 criteria for schizophrenia
- Auditory Hallucinations Rating Scale ≥ 8
- Negative βHCG level if woman
- Effective contraception if woman
- Consent to be included in the study
Who cannot join
- Hearing impairment
- Neurologic disorder
- Other psychiatric disorder from the DSM-5.0 section II
- Developed musical abilities (regular practice of singing or a musical instrument)
- Pregnancy
- Does not consent to be included in the study
- Lacking in legal capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Basic Auditory Processing and Acoustico-verbal Hallucinations: a Pathophysiological Study
Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the population worldwide. Although pathophysiology of this disease remains unclear, a growing interest is emerging for low-level sensory function, acknowledging that deficits in early stages of sensory processing are related to higher-order cognitive disturbances in schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were found correlated with disabilities to discriminate psychoacoustic parameters of sounds.
Read the detailed description
Outcomes: Our main hypothesis is that Auditory Hallucinations Rating Scale (AHRS) scores are correlated with the percentage of wrong answers in a Tone-Matching Task test. The main objective is to assess this correlation. Our other objectives are to assess correlation between AHRS as well as other symptoms scales and psychoacoustic tests assessing intensity, length discrimination of non-verbal tones and self-monitoring abilities. Impact of therapeutic procedures (neuromodulation, psychotherapy) conducted independently of our study on these psychoacoustic tests will also be assessed.
Methods: 30 subjects with schizophrenia will be included. Clinical and psychoacoustic measures will be carried out at J-0. In the case of patients receiving therapeutic procedures independently of our study, new clinical and psychoacoustic measures will be carried out at J+7 and J+30.
- Conditions
- Schizophrenia
- Being tested
- Clinical and psychoacoustic measures
- Keywords
- pitch discrimination, auditory processing disorders, auditory perception, auditory-verbal hallucinations, theory of mind
- Medical subject headings
- Schizophrenia, Auditory Perceptual Disorders, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and psychoacoustic measuresOther
Our study focuses on psychoacoustic tests, specialist care protocols (psychotherapy, neuromodulation ...) being made independently of our study, as part of medical activity of Cerletti care unit or differentiated protocols. Thus, our study shows no individual benefit for the patient. However, a better understanding of the neurophysiological mechanisms underlying auditory hallucinatory phenomenon could allow a better management of these patients in the near future
| Study group | Role | What they receive |
|---|---|---|
| 30 patients with schizophrenia | Experimental | Measure the correlation between the score on the scale psychometric AHRS (Auditory Hallucination Rating Scale) to measure HAV and performance scores discrimination test psychoacoustic Tone Matching Task in subjects suffering from schizophrenia and HAV. Receives: Other: Clinical and psychoacoustic measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage error in discrimination test psychoacoustic Tone Matching Task
Our main hypothesis is that Auditory Hallucinations Rating Scale (AHRS) scores are correlated with the percentage of wrong answers in a Tone-Matching Task test.
Measured: immediately after treatment
Secondary outcomes (1)
Score the item hallucinations of psychometric ( positive and negative syndrome ) scale
Rating Scale(AHRS) as well as other symptoms scales and psychoacoustic tests assessing intensity, length discrimination of non-verbal tones and self-monitoring abilities.
Measured: immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start6 Oct 2016
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haesebaert Frédéric, PH, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887794
- Sponsor's protocol ID
- 2016-A00141-50
- Acronym
- AUDISCHIZ
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2016
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic Auditory Processing and Acoustico-verbal Hallucinations: a Pathophysiological Study
- ClinicalTrials.gov ID
- NCT02887794
- Acronym / sponsor ID
- AUDISCHIZ / 2016-A00141-50
- Conditions
- Schizophrenia
- Keywords
- pitch discrimination, auditory processing disorders, auditory perception, auditory-verbal hallucinations, theory of mind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 2 Sep 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.
Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the population worldwide. Although pathophysiology of this disease remains unclear, a growing interest is emerging for low-level sensory function, acknowledging that deficits in early stages of sensory processing are related to higher-order cognitive disturbances in schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were found correlated with disabilities to discriminate psychoacoustic parameters of sounds.
Detailed description
Outcomes: Our main hypothesis is that Auditory Hallucinations Rating Scale (AHRS) scores are correlated with the percentage of wrong answers in a Tone-Matching Task test. The main objective is to assess this correlation. Our other objectives are to assess correlation between AHRS as well as other symptoms scales and psychoacoustic tests assessing intensity, length discrimination of non-verbal tones and self-monitoring abilities. Impact of therapeutic procedures (neuromodulation, psychotherapy) conducted independently of our study on these psychoacoustic tests will also be assessed.
Methods: 30 subjects with schizophrenia will be included. Clinical and psychoacoustic measures will be carried out at J-0. In the case of patients receiving therapeutic procedures independently of our study, new clinical and psychoacoustic measures will be carried out at J+7 and J+30.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 patients with schizophrenia | Experimental | Other: Clinical and psychoacoustic measuresMeasure the correlation between the score on the scale psychometric AHRS (Auditory Hallucination Rating Scale) to measure HAV and performance scores discrimination test psychoacoustic Tone Matching Task in subjects suffering from schizophrenia and HAV. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18 to 65 years old
- Meeting DSM-5.0 criteria for schizophrenia
- Auditory Hallucinations Rating Scale ≥ 8
- Negative βHCG level if woman
- Effective contraception if woman
Key exclusion criteria (7 listed)
- Hearing impairment
- Neurologic disorder
- Other psychiatric disorder from the DSM-5.0 section II
- Developed musical abilities (regular practice of singing or a musical instrument)
- Pregnancy
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 |
|---|---|---|
| Clinical and psychoacoustic measuresOur study focuses on psychoacoustic tests, specialist care protocols (psychotherapy, neuromodulation ...) being made independently of our study, as part of medical activity of Cerletti care unit or differentiated protocols. Thus, our study shows no individual benefit for the patient. However, a better understanding of the neurophysiological mechanisms underlying auditory hallucinatory phenomenon could allow a better management of these patients in the near future | Other | 30 patients with schizophrenia |
Primary outcome
percentage error in discrimination test psychoacoustic Tone Matching Task
Time frame: immediately after treatment
Our main hypothesis is that Auditory Hallucinations Rating Scale (AHRS) scores are correlated with the percentage of wrong answers in a Tone-Matching Task test.
1 secondary outcome
Score the item hallucinations of psychometric ( positive and negative syndrome ) scale
Time frame: immediately after treatment
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 15 Aug 2022.
- 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.
Haesebaert Frédéric, PH principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and psychoacoustic measures in people with Schizophrenia, run by Hôpital le Vinatier 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 7 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 15 Aug 2022. 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?
percentage error in discrimination test psychoacoustic Tone Matching Task (time frame: immediately after treatment). 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 15 Aug 2022.