Evaluation of Potential Causes of Nap Modulated Tinnitus

NCT ID: NCT05467059

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-09

Study Completion Date

2023-03-10

Brief Summary

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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

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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.

Conditions

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Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Napping

Intervention Type OTHER

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.

Interventions

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Napping

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Lopez-Loreta

UNKNOWN

Sponsor Role collaborator

Service du sommeil de l'hôpital de l'Hôtel-Dieu

UNKNOWN

Sponsor Role collaborator

Robin Guillard EIRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Hôtel-Dieu

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2022-A00197-36

Identifier Type: -

Identifier Source: org_study_id

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