NCT05467059

Evaluation of Potential Causes of Nap Modulated Tinnitus

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Robin Guillard EIRL · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinnitus
• Hearing Disorders
• Ear Diseases
• Otorhinolaryngologic Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-09
• Primary completion: 2022-09-15
• Completion: 2023-03-10
• First posted: 2022-07-20
• Last updated: 2023-03-29

Locations

1 site across 1 country: France