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Completed

NCT Number: NCT05467059

Evaluation of Potential Causes of Nap Modulated Tinnitus

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.

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Key information

Conditions

Tinnitus Apnea Dyssomnias Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sensation Disorders Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Hôtel-Dieu

Paris, 75004, France

About this study

  • - 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Napping

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Correlation between sleep apnea index (number of apnea/hyponea events per hour) and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 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.

  2. Correlation between muscular tension (Electromyogram + Trigger Points) and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 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

  3. Correlation between Middle ear mobility (Impedancemetry) and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 6 naps of 5 minutes sleep each over 2 days of participation

    Using a multi-frequency impedancemeter

  4. Correlation between tubal function (Tubomanometry) and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 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)

  5. Correlation between articular dysfunction (Physiotherapy Tests) and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 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

  6. Correlation between change in averaged electroencephalogram alpha band power and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 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.

  7. Correlation between change in averaged electroencephalogram delta band power and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 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.

  8. Correlation between change in averaged electroencephalogram theta band power and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 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.

  9. Correlation between change in averaged electroencephalogram beta band power and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 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.

  10. Correlation between change in averaged electroencephalogram gamma band power and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 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.

  11. Correlation coefficient between audition thresholds (Audiogram) values and change in minimum masking level of tinnitus (measured in dB)

    Time frame: 6 naps of 5 minutes sleep each over 2 days of participation

    Using an audiometer

Sponsors and collaborators

Lead sponsor

Robin Guillard EIRL

Industry

Collaborators

  • Fondation Lopez-Loreta
  • Service du sommeil de l'hôpital de l'Hôtel-Dieu

Registry information

Official study title

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

Acronym: TinniNap

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 20, 2022
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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