Evaluation of Potential Causes of Nap Modulated Tinnitus (TinniNap)

Robin Guillard EIRL

Status: Completed

Conditions: Hearing Disorders; Otorhinolaryngologic Diseases; Ear Diseases; Tinnitus

Treatments: Other: Napping

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05467059

2022-A00197-36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

37 participants in 1 patient group

Nap-modulated participants

Description:

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.

Treatment:

Other: Napping