Evaluation of Potential Causes of Nap Modulated Tinnitus
- Conditions
- Otorhinolaryngologic DiseasesEar DiseasesTinnitusHearing Disorders
- Interventions
- Other: Napping
- Registration Number
- NCT05467059
- Lead Sponsor
- Robin Guillard EIRL
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Nap-modulated participants Napping 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Hôpital Hôtel-Dieu
🇫🇷Paris, France