Evaluation of Potential Causes of Nap Modulated Tinnitus

Tinnitus Clinical Trial

— TinniNap  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467059
• Other study ID #: 2022-A00197-36
• Status: Completed
• Start date: June 9, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2023
• Source: Robin Guillard EIRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 10, 2023
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ear Diseases
• Hearing Disorders
• Otorhinolaryngologic Diseases
• Tinnitus

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Hôtel-Dieu	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Robin Guillard EIRL	Fondation Lopez-Loreta, Service du sommeil de l'hôpital de l'Hôtel-Dieu

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Average from 6 naps of 5 minutes sleep each over 2 days of participation
Secondary	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.	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	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	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	Correlation between Middle ear mobility (Impedancemetry) and change in minimum masking level of tinnitus (measured in dB)	Using a multi-frequency impedancemeter	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	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)	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	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	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	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.	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	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.	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	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.	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	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.	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	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.	6 naps of 5 minutes sleep each over 2 days of participation
Secondary	Correlation coefficient between audition thresholds (Audiogram) values and change in minimum masking level of tinnitus (measured in dB)	Using an audiometer	6 naps of 5 minutes sleep each over 2 days of participation