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Evaluation of Potential Causes of Nap Modulated Tinnitus

Non-Interventional Study on Evaluation of Potential Causes of Nap Modulated Tinnitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05467059
Acronym
TinniNap
Enrollment
37
Registered
2022-07-20
Start date
2022-06-09
Completion date
2023-03-10
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases, Tinnitus

Keywords

Nap modulated tinnitus, Sleep modulated tinnitus, sleep apneas

Brief 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. The main hypothesis is that sleep apneas could be correlated with an increase of tinnitus intensity.

Detailed description

1. \- 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 2. \- 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.

Interventions

OTHERNapping

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.

Sponsors

Fondation Lopez-Loreta
CollaboratorUNKNOWN
Service du sommeil de l'hôpital de l'Hôtel-Dieu
CollaboratorUNKNOWN
Robin Guillard EIRL
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average change in minimum masking level of tinnitus (measured in dB)Average from 6 naps of 5 minutes sleep each over 2 days of participationMinimum masking level is measured with a wideband 20hz-12kHz noise before and after each nap of 5 minutes sleep.

Secondary

MeasureTime frameDescription
Correlation between muscular tension (Electromyogram + Trigger Points) and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationUsing electromyogram on suprahyoid and masseter muscles, trigger points are done searching for muscle nodes
Correlation between Middle ear mobility (Impedancemetry) and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationUsing a multi-frequency impedancemeter
Correlation between tubal function (Tubomanometry) and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationUsing tubomanometer, the eustachian tube is controled (what pressure through the noise is needed)
Correlation between articular dysfunction (Physiotherapy Tests) and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationUsing cervical rotation test + adapted spurling test + jaw mobility in antepulsion and diduction
Correlation between change in averaged electroencephalogram alpha band power and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationDifference 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.
Correlation between sleep apnea index (number of apnea/hyponea events per hour) and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationSleep apnea index is measured during naps using plethysmography and using air flow measurements through cannulas.
Correlation between change in averaged electroencephalogram theta band power and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationDifference 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.
Correlation between change in averaged electroencephalogram beta band power and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationDifference 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.
Correlation between change in averaged electroencephalogram gamma band power and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationDifference 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.
Correlation coefficient between audition thresholds (Audiogram) values and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationUsing an audiometer
Correlation between change in averaged electroencephalogram delta band power and change in minimum masking level of tinnitus (measured in dB)6 naps of 5 minutes sleep each over 2 days of participationDifference 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026