Cough Management Wellness App for Refractory or Unexplained Chronic Cough

Официальное название

A Prospective Decentralized Investigation of the Effect of a Cough Management Feature Inside a Wellness Application (CoughPro) in Refractory or Unexplained Chronic Cough (RCC/UCC)

Обзор

The goal of this single-cohort clinical trial is to learn whether a smartphone-based Cough Management (CM) program can reduce cough frequency and burden in adults (21-80 years) who have refractory or unexplained chronic cough.  The main questions it aims to answer are: * Does four weeks of using the CM feature in the CoughPro app lower objective cough rate (coughs per hour) compared with each participant's one-week baseline?  * Does the program also lessen cough intensity (bout metrics) and improve patient-reported quality-of-life scores on the Leicester Cough Questionnaire and PGI-S? Participants will: * Wear a Hyfe CoughMonitor smartwatch continuously for 6 weeks (1-week baseline, 4-week intervention, 1-week follow-up), charging it nightly.  * Complete science-based in-app CM lessons based on behavioral cough-suppression therapy and practice the techniques during the 4-week intervention. * Fill out online questionnaires (LCQ and PGI-S) at baseline and at the end of Week 4. * Join a brief exit interview, then return the smartwatch and receive a compensation voucher.

Вмешательства

• Поведенческое Cough Management
  CoughPro is a smartphone wellness application that uses algorithms to detect and count coughs continuously and passively (similar to a "step counter," but for cough). CoughPro also includes a Cough Management (CM) component, which delivers short, structured behavioral lessons (based on BCST) designed to help users recognize their urge to cough and apply cough suppression strategies in real-world settings. The Cough Management wellness feature is the key area of investigation in this study. The
• Устройство CoughMonitor Suite
  CoughMonitor Suite's smartwatch is used in this study to continuously, automatically, and passively monitor cough frequency in a fully privacy-preserving way - no audio is recorded, stored, or synced to the cloud, and no human is in the loop.

Первичные конечные точки

• Change in objective cough rate (coughs/hour) [Срок оценки: From baseline (week minus 1) to end of Week 4]

Вторичные конечные точки (3)

• Change in cough intensity from baseline to end of Week 4 [Срок оценки: Fom baseline (week minus 1) to end of week 4]
• Change in subjective impression of cough burden [Срок оценки: From baseline to 4 weeks after starting the intervention.]
• Change in subjective impression of cough burden [Срок оценки: From baseline to 4 weeks after starting the intervention.]

Критерии участия

Критерии включения

• Age 21 or older.
• Currently suffering from a cough that started at least 8 weeks ago that is largely unproductive (i.e., at least 50% of the time the cough produces zero mucus that needs to be spit out or swallowed).
• Normal chest X-ray or chest CT scan at some point that was prescribed specifically for their cough.
• At least one physician visit for cough with standard-of-care therapy but inadequate symptom relief.
• Stability of treatment: willing to avoid new cough treatments during study or report changes if they occur.
• Ability to comply: willing/able to wear the watch daily for the required duration of study and to complete all required questionnaires.
• Informed consent: understanding of the study procedures and agreement to comply with protocol.

Критерии исключения

• Recent upper respiratory infection (past 4 weeks).
• History of hemoptysis (coughing up blood) since onset of the current cough.
• Current smoker (incl. vaping) of any substance.
• ≥10 consecutive pack-years smoking history within <10 years prior to screening.
• Diagnosed with a chronic lung condition (COPD, emphysema, lung cancer, IPF, chronic bronchitis, asthma). Note: Suspected asthma without confirmed diagnosis or benefit from asthma therapy is not an exclusion.
• Current or past head/neck cancer.
• Difficulty swallowing.
• On ACE inhibitors, such as Benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik)
• Prior treatment for cough by a speech-language pathologist.
• Living with another individual with a frequent cough that would interfere with monitoring.
• Participation in any cough intervention study within 30 days or 5 half-lives of the intervention.
• Major scheduled surgery during the study period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Hyfe Inc. — Wilmington

Публикации

• Sundholm N, Shelly S, Wright ML, Reynolds J, Slovarp L, Gillespie AI. Effect of Behavioral Cough Suppression Therapy Delivered via Telehealth. J Voice. 2025 May;39(3):851.e1-851.e5. doi: 10.1016/j.jvoice.2022.11.015. Epub 2022 Dec 20. PMID 36550001
• Chaccour C, Sanchez-Olivieri I, Siegel S, Megson G, Winthrop KL, Botella JB, de-Torres JP, Jover L, Brew J, Kafentzis G, Galvosas M, Rudd M, Small P. Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study. Sci Rep. 2025 Jan 6;15(1):880. doi: 10.1038/s41598-025-85341-3. PMID 39762316
• Yi B, Wang S, Xu X, Yu L. Efficacy of behavioral cough suppression therapy for refractory chronic cough or unexplained chronic cough: a meta-analysis of randomized controlled trials. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241305952. doi: 10.1177/17534666241305952. PMID 39707881
• Chamberlain Mitchell SA, Garrod R, Clark L, Douiri A, Parker SM, Ellis J, Fowler SJ, Ludlow S, Hull JH, Chung KF, Lee KK, Bellas H, Pandyan A, Birring SS. Physiotherapy, and speech and language therapy intervention for patients with refractory chronic cough: a multicentre randomised control trial. Thorax. 2017 Feb;72(2):129-136. doi: 10.1136/thoraxjnl-2016-208843. Epub 2016 Sep 28. PMID 27682331
• Slovarp LJ, Jette ME, Gillespie AI, Reynolds JE, Barkmeier-Kraemer JM. Evaluation and Management Outcomes and Burdens in Patients with Refractory Chronic Cough Referred for Behavioral Cough Suppression Therapy. Lung. 2021 Jun;199(3):263-271. doi: 10.1007/s00408-021-00442-w. Epub 2021 Apr 5. PMID 33821355

Идентификаторы

NCT: NCT07070895 · CPCoMg-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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