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Recruiting NCT07488598

Efficacy of Behavioral Therapy for Chronic Refractory Cough

No phase Interventional Chronic Cough

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral Therapy.
Who it may be relevant to
Registry conditions: Chronic Cough. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of Behavioral Therapy for Chronic Refractory Cough in Patients With Laryngeal Hyperresponsiveness

Overview

Chronic cough is defined as cough persisting for more than eight weeks. It is a common clinical problem that significantly impairs patients' physical, psychological, and social quality of life. Chronic cough remains a diagnostic and therapeutic challenge despite systematic evaluation and treatment of common etiologies such as asthma, gastroesophageal reflux disease

Detailed description

Chronic cough is defined as cough persisting for more than eight weeks. It is a common clinical problem that significantly impairs patients' physical, psychological, and social quality of life. Chronic cough remains a diagnostic and therapeutic challenge despite systematic evaluation and treatment of common etiologies such as asthma, gastroesophageal reflux disease .

A substantial proportion of patients continue to experience persistent symptoms and are increasingly classified under the umbrella of cough hypersensitivity syndrome, characterized by an exaggerated cough response to low-level mechanical, chemical, or thermal stimuli .

Laryngeal hyperresponsiveness represents a central pathophysiological feature of upper air way cough syndrome and is associated with heightened sensory and motor responses of the larynx, leading to symptoms such as throat irritation, dysphonia, frequent throat clearing, and cough triggered by talking, laughing, cold air, or exposure to strong odors.

Pharmacological therapies often provide limited or inconsistent benefit in those patients,prompting growing interest in non-pharmacological approaches, particularly behavioral cough suppression therapy delivered by speech-language pathologists.

Behavioral therapy is a multimodal intervention incorporating patient education, cough suppression techniques, breathing retraining, vocal hygiene counseling, and strategies aimed at reducing laryngeal irritation and maladaptive cough behaviors and improve voluntary control of the urge to cough.

Randomized controlled trials and observational studies have demonstrated that behavioral therapy can significantly reduce cough frequency, cough reflex sensitivity, and cough-related quality-of-life impairment, with particular benefit observed in patients with prominent laryngeal symptoms and heightened urge-to-cough.

A recent meta-analysis of 12 randomized and self-controlled trials provides robust evidence for Behavioral Cough Suppression Therapy (BCST), showing it significantly improves Leicester Cough Questionnaire scores and reduces objective cough frequency in patients with refractory or unexplained chronic cough.

Furthermore, a specific protocol known as Physiotherapy and Speech and Language Therapy Intervention (PSALTI) has demonstrated a 41% reduction in cough frequency in clinical trials.

Despite the Advantages of speech pathology intervention, there is limited guidance in the literature on when patients should be referred for treatment. Also, heterogeneity in patient selection, diagnostic criteria, and outcome measures highlights the Need for further evaluation of the Efficacy of behavioral therapy in well-defined population with laryngeal hyperresponsivness.

Interventions

  • Behavioral Behavioral Therapy
    to evaluate the efficacy of behavioral therapy for chronic cough in patients with laryngeal hyperresponsiveness in order to assess its role as a non-pharmacological management strategy. This will provide an efficient plan of therapy for such challenging condition.

Primary outcome measures

  • Treatment of Chronic Cough [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Eligible participants are adults aged ≥18 years i.e. normal chest radiograph.
  • participants with chronic cough persisting for more than eight weeks that is refractory to standard medical treatment for common causes of chronic cough, including asthma, gastroesophageal reflux disease .
  • Participants are required to exhibit clinical features suggestive of laryngeal hyperresponsiveness, such as cough triggered by phonation, laughter, cold air, or irritant exposure, with associated laryngeal symptoms including throat irritation, dysphonia, or frequent throat clearing.

Exclusion criteria

  • Patients are excluded if they are current smokers or had ceased smoking within six months
  • patients have evidence of active pulmonary or cardiac disease, recent respiratory tract infection, recent angiotensin-converting enzyme inhibitor use.
  • significant structural laryngeal pathology, neurological disorders affecting cough reflex control, or inability to comply with study procedures.
  • Head \&neck pathology e.g sinusitis, glottal insufficiency or primary muscle tension dysphonia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assuit University hospitals — Asyut

Identifiers

NCT: NCT07488598 · Chronic Refractory Cough

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗