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Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease (ADHERE)

24 maggio 2017 aggiornato da: Michael Vaezi, Vanderbilt University Medical Center

ADHERE Study: Application of Dx-pH Catheter for Extra-esophageal Reflux Evaluation

The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophageal pH with hypopharyngeal pH using both the "short" and the "long" catheters in patients.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Gastroesophageal reflux disease (GERD) has been linked to many disorders and can be diagnosed through a variety of modalities utilizing 24 hour ambulatory pH monitoring which can register the duration, pattern and symptom correlation of distal esophageal acid exposure. This can be accomplished via a catheter probe connected from outside the body and placed through a nostril, advanced past the hypopharynx and down into the distal esophagus. Or, a small pH detector temporarily implanted in the distal esophagus during endoscopy can record reflux events. However, despite available technologies, there has long been a deficiency in detecting extra-esophageal reflux in the upper esophagus/ hypopharynx. This is of interest for gastroenterologists, otolaryngologists, and pulmonologists in the evaluation of extra-esophageal reflux as a potential culprit for asthma, chronic cough, laryngitis, globus, and non-cardiac chest pain. Until now, there has not been a device sensitive enough for accurately detecting extra-esophageal reflux (EERD) and clinicians have relied upon subjective response to empiric treatment with acid reducing medications to determine whether acid reflux was at the root of the symptoms. There are currently no well designed published studies with this device to assess its role in this group of difficult to treat patients.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

47

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37232
        • Vanderbilt Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Male and female volunteers aged 18 to 65 years old.
  2. Control group: No known history of GERD or EERD or prior PPI use.
  3. GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.
  4. EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.

Exclusion Criteria:

  1. Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.
  2. Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
  3. Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
  4. Expected non-compliance.
  5. Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
  6. Recent nasal surgery or nasal obstruction.
  7. Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)
  8. Pregnancy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 1
Healthy volunteers with no history of GERD or EERD or Proton Pump Inhibitor (PPI) use
Dispositivo: Dx-pH Probe
24 hour ph monitoring
Procedura: Manometry
procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)
Sperimentale: 2
subject is known to have GERD based on symptoms and previous positive response to PPI
Dispositivo: Dx-pH Probe
24 hour ph monitoring
Procedura: Manometry
procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)
Sperimentale: 3
subject is known to have EERD based on symptoms and previous positive response to PPI
Dispositivo: Dx-pH Probe
24 hour ph monitoring
Procedura: Manometry
procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Decrease in pH From Baseline to <4
Lasso di tempo: 24 hours
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.
24 hours
Decrease in pH From Baseline to <5
Lasso di tempo: 24 hours
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.
24 hours
Decrease in pH From Baseline to <6
Lasso di tempo: 24 hours
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.
24 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Reflux Events
Lasso di tempo: 24 hours
Reflux event was calculated for a drop in pH from baseline to <6 and each event had to last more than 5 seconds and could not be during the meals.
24 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Vanderbilt University Medical Center

Investigatori

  • Investigatore principale: Michael F Vaezi, MD, PhD, MS, Vanderbilt University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2006

Completamento primario (Effettivo)

1 settembre 2012

Completamento dello studio (Effettivo)

1 luglio 2013

Date di iscrizione allo studio

Primo inviato

13 ottobre 2006

Primo inviato che soddisfa i criteri di controllo qualità

13 ottobre 2006

Primo Inserito (Stima)

16 ottobre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 giugno 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 060860

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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