Evaluation of Potential Causes of Nap Modulated Tinnitus
NCT ID: NCT05467059
Last Updated: 2023-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
37 participants
OBSERVATIONAL
2022-06-09
2023-03-10
Brief Summary
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The main hypothesis is that sleep apneas could be correlated with an increase of tinnitus intensity.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Fondation Lopez-Loreta
UNKNOWN
Service du sommeil de l'hôpital de l'Hôtel-Dieu
UNKNOWN
Robin Guillard EIRL
INDUSTRY
Responsible Party
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Locations
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Hôpital Hôtel-Dieu
Paris, , France
Countries
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Other Identifiers
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2022-A00197-36
Identifier Type: -
Identifier Source: org_study_id
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