- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05467059
Evaluation of Potential Causes of Nap Modulated Tinnitus (TinniNap)
March 27, 2023 updated by: Robin Guillard EIRL
Non-Interventional Study on Evaluation of Potential Causes of Nap Modulated Tinnitus
The proposed research is a non-interventional study made to evaluate different measurements on 1 group of participants, before and after taking a nap, aiming to potentially guide future investigations on nap-modulated tinnitus to better understand this phenomenon.
The main hypothesis is that sleep apneas could be correlated with an increase of tinnitus intensity.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
- - Background : Tinnitus is a really important concern due to its high prevalence (10% world population) and its deteriorating effects on life quality. Subjective tinnitus still remains a scientific enigma because of its partial elucidation. The limited knowledge on its causes can be partially attributed to its intrinsic heterogeneity. In questionnaires previous to this study, 34% of participants showed a characteristic symptomatology of interactions between tinnitus and their sleep : they feel their tinnitus at its maximum intensity after sleeping periods (nap and sleep). In most cases they describe a frank rise of the intensity, compared in scientific papers to the "exploding head syndrome". Therefore this study aims to determine what are the main physiopathological processes correlated to the rises of tinnitus
- - Objectives : Estimate the correlations between tinnitus intensity changes (before and after the nap) and the number of sleep apneas. Secondary measurements are described in the outcome field.
Study Type
Observational
Enrollment (Actual)
37
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Paris, France, 75004
- Hôpital Hôtel-Dieu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study population is recruited through questionnaires done on different platforms including : SIOPI app, previous potential participants or associations.
A lesser part of the study group comes from suggestions of ENTs/Doctors.
Description
Inclusion Criteria:
- Affiliated participant or beneficiary of a social security scheme
- Acceptation of protocol and signature of non-opposition
- Frankly nap-modulated tinnitus (increase of intensity after napping)
- Tinnitus maskable by white noise equal or inferior to 85 dB
Exclusion Criteria:
- Persons under juridic protection (guardianship or safeguard of justice)
- Clear cognitive incapacity (not understanding/nor apprehend the study tasks)
- Pregnancy or breast feeding
- Epilepsia
- Non-equilibrated chronic metabolic pathology
- Non-equilibrated psychiatric pathology
- Difficulty in napping
- Important hyperacusis
- Meniere's disease, fast fluctuating tinnitus (seconds or minutes), pulsatile tinnitus
- Any patient benefiting of a tinnitus treatment that was modified in the last 3 months
- Superficial wound, open or partially not cauterized
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Nap-modulated participants
Patients with rises of tinnitus intensity after taking a nap or after a short period of sleep.
If possible with a characteristic ON/OFF tinnitus (sometimes they have a tinnitus for several days and then stop for several days also).
This condition is determined by previous questionnaire.
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Patients are already equipped with electrodes when they pass a test battery before the nap to evaluate mechanisms potentially correlated with tinnitus modulation.
Then they do a nap, the nap is stopped when several periods of sleep are seen on EEG (electroencephalogram).
Then the test battery is done backwards to evaluate the same measures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average change in minimum masking level of tinnitus (measured in dB)
Time Frame: Average from 6 naps of 5 minutes sleep each over 2 days of participation
|
Minimum masking level is measured with a wideband 20hz-12kHz noise before and after each nap of 5 minutes sleep.
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Average from 6 naps of 5 minutes sleep each over 2 days of participation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between sleep apnea index (number of apnea/hyponea events per hour) and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
|
Sleep apnea index is measured during naps using plethysmography and using air flow measurements through cannulas.
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6 naps of 5 minutes sleep each over 2 days of participation
|
Correlation between muscular tension (Electromyogram + Trigger Points) and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
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Using electromyogram on suprahyoid and masseter muscles, trigger points are done searching for muscle nodes
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6 naps of 5 minutes sleep each over 2 days of participation
|
Correlation between Middle ear mobility (Impedancemetry) and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
|
Using a multi-frequency impedancemeter
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6 naps of 5 minutes sleep each over 2 days of participation
|
Correlation between tubal function (Tubomanometry) and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
|
Using tubomanometer, the eustachian tube is controled (what pressure through the noise is needed)
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6 naps of 5 minutes sleep each over 2 days of participation
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Correlation between articular dysfunction (Physiotherapy Tests) and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
|
Using cervical rotation test + adapted spurling test + jaw mobility in antepulsion and diduction
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6 naps of 5 minutes sleep each over 2 days of participation
|
Correlation between change in averaged electroencephalogram alpha band power and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
|
Difference of alpha band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
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6 naps of 5 minutes sleep each over 2 days of participation
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Correlation between change in averaged electroencephalogram delta band power and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
|
Difference of delta band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
|
6 naps of 5 minutes sleep each over 2 days of participation
|
Correlation between change in averaged electroencephalogram theta band power and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
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Difference of theta band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
|
6 naps of 5 minutes sleep each over 2 days of participation
|
Correlation between change in averaged electroencephalogram beta band power and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
|
Difference of beta band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
|
6 naps of 5 minutes sleep each over 2 days of participation
|
Correlation between change in averaged electroencephalogram gamma band power and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
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Difference of gamma band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
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6 naps of 5 minutes sleep each over 2 days of participation
|
Correlation coefficient between audition thresholds (Audiogram) values and change in minimum masking level of tinnitus (measured in dB)
Time Frame: 6 naps of 5 minutes sleep each over 2 days of participation
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Using an audiometer
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6 naps of 5 minutes sleep each over 2 days of participation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2022
Primary Completion (Actual)
September 15, 2022
Study Completion (Actual)
March 10, 2023
Study Registration Dates
First Submitted
May 24, 2022
First Submitted That Met QC Criteria
July 15, 2022
First Posted (Actual)
July 20, 2022
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A00197-36
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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