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An Exploratory Study of the Efficacy of a heat and moisture exchanger (Provox LifeTM Home HME) in Patients with Total Laryngectomy

An Exploratory Study of the Efficacy of a heat and moisture exchanger (Provox LifeTM Home HME) in Patients with Total Laryngectomy - An Exploratory Study of the Efficacy of a heat and moisture exchanger (Provox LifeTM Home HME) in Patients with Total Laryngectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050612
Enrollment
25
Registered
2023-04-01
Start date
2023-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

After total laryngectomy

Interventions

Patients wear the new a heat and moisture exchanger (Provox LifeTM Home HME) and the existing a heat and moisture exchanger for 6 weeks each and complete a questionnaire about the frequency of coughin

Sponsors

Kobe University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients who have undergone total laryngectomy 2. 18 years of age or older 3. more than 3 months after total laryngectomy 4. more than 6 weeks after completion of postoperative radiation therapy 5. Patients who have been using a heat and moisture exchanger other than Provox LifeTM Home HME for more than 3 months. 6. Patients who are clinically judged to be eligible for Provox LifeTM Home HME. 7. Patients who have given written consent to the study

Exclusion criteria

Exclusion criteria: 1.Patients who have never used a heat and moisture exchanger before the start of this study 2. Patients who cannot put on and take off a heat and moisture exchanger by themselves 3. Patients with recurrent tumor or metastatic disease 4. Patients with pulmonary infection or exacerbation of respiratory disease such as COPD within one month. 5. Patients who are unable to understand the questionnaire or consent form due to cognitive decline. 6. Patients who have changed the dosage of cough suppressants or expectorants within one month prior to entry into the study. 7. Patients with skin disorders requiring treatment at the site of a heat and moisture exchanger

Design outcomes

Primary

MeasureTime frame
Change in number of coughs per day

Secondary

MeasureTime frame
Change in color of sputum Skin disorders QOL

Countries

Japan

Contacts

Public ContactHiroko Takeda

Kobe University Department of Otorhinolaryngology-Head and Neck Surgery

piyo1992@med.kobe-u.ac.jp078-382-6024

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026