Long Term Effects of Heat and Moisture Exchangers (HMEs)

Laryngectomy; Status Clinical Trial

Official title:

Long Term Effects of Heat and Moisture Exchangers (HMEs) (Provox® Life™) on Pulmonary Symptoms in Laryngectomized Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06084611
• Other study ID #: PL_Brazil
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: Atos Medical AB
• Contact: Rafael De Cicco
• Phone: +55 11 999649920
• Email: rafaelcicco[@]doutorarnaldo.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngectomy; Status

Intervention

Device:
• Provox Life
Compliant use of Provox Life HMEs

Locations

Country	Name	City	State
Brazil	Instituto de Cancer Dr. Arnaldo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Atos Medical AB	Instituto de Cancer Dr Arnaldo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CASA-Q Score	assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.	Baseline, 3 months, 6 months, 9 months
Secondary	Number of involuntary coughs per 24 hours	Patient reported, recorded by tally sheeting	Baseline, 3 months, 6 months, 9 months
Secondary	Forced Expectoration	Patient reported, recorded by tally sheeting	Baseline, 3 months, 6 months, 9 months
Secondary	Quality of Life by EQ-5D-5L	patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility	Baseline, 3 months, 6 months, 9 months
Secondary	Jenkins sleep evaluation questionnaire	Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances	Baseline, 3 months, 6 months, 9 months
Secondary	Questionnaire to assess Shortness of Breath	from Ackerstaff et al., 1993	Baseline, 3 months, 6 months, 9 months
Secondary	Voice handicap Index	patient reported outcome, score from 0-40, with higher scores indicating greater voice-related handicap.	Baseline, 3 months, 6 months, 9 months
Secondary	Consumption of medical devices (Number of devices used)	Number of devices used, by use of patient diary recoding number of devices used	Baseline, 3 months, 6 months, 9 months
Secondary	Study-specific questionnaire to assess number of complications and medical treatments	Study specific questionnaire to record complications and consumption of medications, diagnostics, treatment, medical care, medical transportation, sick leave	Baseline, 3 months, 6 months, 9 months