Terminé

Comparison of Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing in Children and Adults

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Ce qui est collecté

Collecte de données

Données recueillies à un instant précis - Transversale
Qui peut participer

De 5 à 60 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Cas témoins

Analyse de profils avec et sans la maladie pour comprendre ce qui pourrait l'avoir favorisée.
Observationnel
Date de début : février 2019
Voir le détail du protocole

Résumé

Sponsor principalCuneyt M. Alper
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 27 février 2019

Date à laquelle le premier participant a commencé l'étude.

There is no current universally-accepted set of functional tests or scoring systems for the diagnosis of ETD or measure of the pressure-regulating function of the ET; current practice shows that the diagnosis of ETD relies largely on clinical observation. Though there are several tests that have been developed to characterize ETF, many of them require specialized equipment and trained personnel to administer the test, which are only available in specialized testing centers. As such, this study aims to compare the use of the EarPopper plus tympanometry to Tubomanometry as a ETF test. Tubomanometry is a simple in-office test based on the Politzer maneuver, in which air is blown into one of the nostrils while occluding the contralateral nostril and swallowing. The tubomanometer consists of an air pump attached to a manometer to adjust the target pressure, a two-pronged nose piece to deliver a controlled airflow to the nostrils and an external ear canal sensor to detect displacement of the tympanic membrane (TM). Since the middle ear is a closed system, displacement of the TM during a swallow is considered a successful ET opening. Tubomanometry is easily tolerated by both adults and children is currently used most widely to evaluate ETF changes after ET balloon dilation. The EarPopper is, like the tubomanometer, a modified politzer device and is used as a treatment device for ET obstruction. It introduces a continuous airflow into the nostril and has no external ear canal probe. The user perceives the ET opening as a subjective sensation of ear fulness. In this pilot study, the investigators will test the feasibility of a new ETF test protocol that will use the EarPopper to trigger the opening of the ET followed by a tympanogram to confirm if there was a change in middle ear pressure. The investigators expect that the combination of these two devices will be comparable to the Tubomanometry test, which will also be performed in the same test session. Previous studies show that ET opening efficiency is determined by the coordinated function of paratubal muscles, especially of the levator (mLVP) and tensor veli palatini (mTVP) muscles. Nasal endoscopy video recordings have shown a large variability in soft palate closure, as it depends largely on individual effort. For this reason, besides swallowing, the investigators will also employ two additional methods to standardize the elevation of the soft palate and facilitate the opening of the ET: the Fish maneuver (puffing the cheeks and blowing out against a closed mouth) and the EMST-150 device (blowing into the device with a preset low and high resistances). As part of the development of this new testing protocol, these three maneuvers will be used during the EarPopper plus tympanometry and Tubomanometry tests. They will be performed during the EarPopper test, with concurrent video-otoscopy recordings to detect movement of the tympanic membrane that could be interpreted as an ET opening, and during trans-nasal video-endoscopy to record the movement and positioning of the soft palate. The investigators expect that, in comparing the maneuvers performed during EarPopper plus tympanometry and Tubomanometry tests, they will assess the feasibility of the protocol, define maneuvers to standardize paratubal muscular contraction and determine if the EarPopper plus tympanometry measurements are comparable to Tubomanometry.

Titre officielComparison of Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing in Children and Adults
NCT03850197
Sponsor principalCuneyt M. Alper
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

30 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Cas témoins

Ce type d'étude compare des personnes atteintes d'une maladie à d'autres qui ne le sont pas, afin de comprendre quels facteurs ou expositions passées pourraient avoir joué un rôle dans l'apparition de la maladie.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 5 à 60 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Critères

INCLUSION CRITERIA ETD participants: * Bilaterally intact tympanic membranes * aged 5 to 60; generally good health * ability to understand and give informed consent * history of myringotomy tubes, recurrent middle ear infections, recurrent middle ear fluids, or prior ETD diagnosis * ability to perform maneuvers that will be done during the testing protocol. Control participants * Bilaterally intact tympanic membranes * aged 5 to 60 * generally good health * ability to understand and give informed consent * no personal history of recurrent otitis media or other middle--ear disease * ability to perform maneuvers that will be done during the testing protocol * no difficulty equalizing middle--ear pressures in daily life. EXCLUSION CRITERIA ETD participants: * Cold/allergic rhinitis (temporary) on presentation * current dental problem or dental work within 7 days (temporary) * history of ossicular reconstruction * history of tympanoplasty * syndromes predisposing to otitis media * extant middle--ear disease * inability to complete testing protocols * tympanic membrane perforation * abnormal tympanogram (type B tympanogram) * BMI \>40 * history of congenital heart disease * prior radiation to head and neck * uncontrolled respiratory disease * any medical condition or use of medication for which the study physician feels study procedures would not be in the subject's best interest. * In adults, a positive urine pregnancy test (in females), blood pressure above 140/90, glaucoma, and sensitivity to drugs used to prepare the nose for endoscopic examination will also exclude potential participants. Control participants: * (in addition to above) significant middle--ear disease history * evidence of middle ear pathology.

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Objectifs de l'étude

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

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Cette étude comporte 1 site

Suspendu

ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118

Pittsburgh, United StatesOuvrir ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118 dans Google Maps
Terminé1 Centres d'Étude