TinniNap: Evaluation of Potential Causes of Nap Modulated Tinnitus

Sponsor

Robin Guillard EIRL (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05467059

Collaborator

Fondation Lopez-Loreta (Other), Service du sommeil de l'hôpital de l'Hôtel-Dieu (Other)

Enrollment

Location

2.8

Anticipated Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases	Other: Napping

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 9, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	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.	Other: 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.

Arm

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Average change in minimum masking level of tinnitus (measured in dB) [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.

Secondary Outcome Measures

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 participation]
Sleep apnea index is measured during naps using plethysmography and using air flow measurements through cannulas.
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 participation]
Using 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 participation]
Using 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 participation]
Using 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 participation]
Using 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 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.
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 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.
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 participation]
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.
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 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.
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 participation]
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.
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 participation]
Using an audiometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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