Evaluation of Potential Causes of Nap Modulated Tinnitus

NCT05467059 | Completed

• 1 other identifier: 2022-A00197-36
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases

Keywords

Nap modulated tinnitus; Sleep modulated tinnitus; sleep apneas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

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

Interventions

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.

Nap-modulated participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robin Guillard EIRL: lead
• Fondation Lopez-Loreta: collaborator
• Service du sommeil de l'hôpital de l'Hôtel-Dieu: collaborator

Study Sites (1)

Hôpital Hôtel-Dieu

Paris, 75004, France

Location

MeSH Terms

Conditions

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 17 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: July 20, 2022
• Study Start: June 9, 2022
• Primary Completion: September 15, 2022
• Study Completion: March 10, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)