Evaluating the long-term effects of heat and moisture exchangers for laryngectomized patients
Long Term Effects of Heat and Moisture Exchangers (HMEs) (Provox® Life™) on Pulmonary Symptoms in Laryngectomized Patients
This study is testing if using special devices called heat and moisture exchangers can help people who have had their voice box removed breathe better and feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Atos Medical AB Industry-sponsored |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06084611 on ClinicalTrials.gov |
What this trial studies
This study assesses the long-term impact of using Provox Life heat and moisture exchangers (HMEs) on pulmonary symptoms in patients who have undergone total laryngectomy. It aims to determine how these devices can improve respiratory function and overall quality of life for individuals post-surgery. Participants must be at least 18 years old and have had their laryngectomy for more than three months, ensuring they are stable enough to evaluate the effects of the HME. The study excludes those currently using HMEs or with certain medical conditions that could interfere with the assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone total laryngectomy more than three months prior.
Not a fit: Patients currently using HMEs or those with active medical issues that prevent HME use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve respiratory health and quality of life for laryngectomized patients.
How similar studies have performed: While the specific use of Provox Life HMEs in this context may be novel, similar studies have shown positive outcomes with HMEs in improving respiratory function in laryngectomized patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Total laryngectomy, irrespective of pharynx reconstruction method * 18 years or older * Longer than 3 months after total laryngectomy * Longer than 6 weeks after postoperative radiotherapy Exclusion Criteria: * Current use of HMEs (within last 3 months) * Medical problems prohibiting the use of HME * Active recurrent or metastatic disease (medical deterioration) * Recent pulmonary infections/unstable pulmonary condition * Insufficient physical, cognitive, or mental ability required to attach, remove or operate the devices themselves * Low tidal volumes * Unable to understand the Participant Information and/or unable to give Informed Consent
Where this trial is running
São Paulo
- Instituto de Cancer Dr. Arnaldo — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Rafael De Cicco
- Email: rafaelcicco@doutorarnaldo.org
- Phone: +55 11 999649920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.