Evaluation of Potential Causes of Nap Modulated Tinnitus (TinniNap)

March 27, 2023 updated by: Robin Guillard EIRL

Non-Interventional Study on 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75004
        • Hôpital Hôtel-Dieu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Average from 6 naps of 5 minutes sleep each over 2 days of participation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 naps of 5 minutes sleep each over 2 days of participation
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
6 naps of 5 minutes sleep each over 2 days of participation
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
6 naps of 5 minutes sleep each over 2 days of participation
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)
6 naps of 5 minutes sleep each over 2 days of participation
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 naps of 5 minutes sleep each over 2 days of participation
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.
6 naps of 5 minutes sleep each over 2 days of participation
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.
6 naps of 5 minutes sleep each over 2 days of participation
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.
6 naps of 5 minutes sleep each over 2 days of participation
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.
6 naps of 5 minutes sleep each over 2 days of participation
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.
6 naps of 5 minutes sleep each over 2 days of participation
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
6 naps of 5 minutes sleep each over 2 days of participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Robin Guillard EIRL

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondation Lopez-Loreta
Service du sommeil de l'hôpital de l'Hôtel-Dieu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-A00197-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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