TinnitusTinniNapNCT05467059
Evaluation of Potential Causes of Nap Modulated Tinnitus
An observational study of Tinnitus and Hearing Disorders, run by Robin Guillard EIRL at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus, Hearing Disorders, Ear Diseases
- What is being tested?
- Napping
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2022to 10 Mar 2023
- How long will I take part?
- 17 Days
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Napping
- Keywords
- Nap modulated tinnitus, Sleep modulated tinnitus, sleep apneas
- Medical subject headings
- Tinnitus, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NappingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Napping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in minimum masking level of tinnitus (measured in dB)
Minimum masking level is measured with a wideband 20hz-12kHz noise before and after each nap of 5 minutes sleep.
Measured: Average from 6 naps of 5 minutes sleep each over 2 days of participation
Secondary outcomes (11)
Correlation between sleep apnea index (number of apnea/hyponea events per hour) and change in minimum masking level of tinnitus (measured in dB)
Sleep apnea index is measured during naps using plethysmography and using air flow measurements through cannulas.
Measured: 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)
Using electromyogram on suprahyoid and masseter muscles, trigger points are done searching for muscle nodes
Measured: 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)
Using a multi-frequency impedancemeter
Measured: 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)
Using tubomanometer, the eustachian tube is controled (what pressure through the noise is needed)
Measured: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between articular dysfunction (Physiotherapy Tests) and change in minimum masking level of tinnitus (measured in dB)
Using cervical rotation test + adapted spurling test + jaw mobility in antepulsion and diduction
Measured: 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)
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.
Measured: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between change in averaged electroencephalogram delta band power and change in minimum masking level of tinnitus (measured in dB)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Using an audiometer
Measured: 6 naps of 5 minutes sleep each over 2 days of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start9 Jun 2022
- Primary completion15 Sep 2022
- Study completion10 Mar 2023
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 TinnitusStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
- Target duration
- 17 Days
Sponsor and investigators
- Lead sponsor
- Robin Guillard EIRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fondation Lopez-Loreta, Service du sommeil de l'hôpital de l'Hôtel-Dieu
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467059
- Sponsor's protocol ID
- 2022-A00197-36
- Acronym
- TinniNap
- Status last verified
- Mar 2023
- First submitted
- 24 May 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guillard R, Philippe V, Hessas A, Faraut B, Michiels S, Park M, Congedo M, Londero A, Leger D. Why does tinnitus vary with naps? A polysomnographic prospective study exploring the somatosensory hypothesis. Hear Res. 2025 Jan;455:109152. doi: 10.1016/j.heares.2024.109152. Epub 2024 Dec 4.
PubMed 39644685
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study on Evaluation of Potential Causes of Nap Modulated Tinnitus
- ClinicalTrials.gov ID
- NCT05467059
- Acronym / sponsor ID
- TinniNap / 2022-A00197-36
- Keywords
- Nap modulated tinnitus, Sleep modulated tinnitus, sleep apneas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Robin Guillard EIRLIndustry (pharma, biotech, devices)
- Collaborators
- Fondation Lopez-Loreta, Service du sommeil de l'hôpital de l'Hôtel-Dieu
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 20 Jul 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 17 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nap-modulated participants | – | Other: NappingPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| NappingPatients 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. | Other | Nap-modulated participants |
Primary outcome
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.
11 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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 29 Mar 2023.
- Derived from this study: PubMed 39644685Guillard R, Philippe V, Hessas A, Faraut B, Michiels S, Park M, Congedo M, Londero A, Leger D. Why does tinnitus vary with naps? A polysomnographic prospective study exploring the somatosensory hypothesis. Hear Res. 2025 Jan;455:109152. doi: 10.1016/j.heares.2024.109152. Epub 2024 Dec 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus and Hearing Disorders, run by Robin Guillard EIRL 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 11 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 29 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.
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?
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). 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 NCT05467059, 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 29 Mar 2023.