Clinical trial NCT05467059: Evaluation of Potential Causes of Nap Modulated Tinnitus
Official title: Non-Interventional Study on Evaluation of Potential Causes of Nap Modulated Tinnitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Keywords: Nap modulated tinnitus
Sleep modulated tinnitus
sleep apneas
Lead sponsor: Robin Guillard EIRL
Sponsor class: INDUSTRY
Collaborators: name: Fondation Lopez-Loreta
name: Service du sommeil de l'hôpital de l'Hôtel-Dieu
First posted: 2022-07-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average change in minimum masking level of tinnitus (measured in dB)
timeFrame: Average from 6 naps of 5 minutes sleep each over 2 days of participation
Secondary outcomes:
measure: Correlation between sleep apnea index (number of apnea/hyponea events per hour) and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation between muscular tension (Electromyogram + Trigger Points) and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation between Middle ear mobility (Impedancemetry) and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation between tubal function (Tubomanometry) and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation between articular dysfunction (Physiotherapy Tests) and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation between change in averaged electroencephalogram alpha band power and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation between change in averaged electroencephalogram delta band power and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation between change in averaged electroencephalogram theta band power and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation between change in averaged electroencephalogram beta band power and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation between change in averaged electroencephalogram gamma band power and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
measure: Correlation coefficient between audition thresholds (Audiogram) values and change in minimum masking level of tinnitus (measured in dB)
timeFrame: 6 naps of 5 minutes sleep each over 2 days of participation
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Hôtel-Dieu
Study officials:
References: