Long Term Effects of Heat and Moisture Exchangers (HMEs)

Not Applicable

Recruiting

• Conditions: Laryngectomy; Status
• Interventions: Device: Provox Life

• Registration Number: NCT06084611
• Lead Sponsor: Atos Medical AB

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-16
• Study Start: 2024-03-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Provox Life HME	Provox Life	Use of Provox Life HMEs and attachment

Primary Outcome Measures

Name	Time	Method
CASA-Q Score	Baseline, 3 months, 6 months, 9 months	assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.

Secondary Outcome Measures

Name	Time	Method
Quality of Life by EQ-5D-5L	Baseline, 3 months, 6 months, 9 months	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
Jenkins sleep evaluation questionnaire	Baseline, 3 months, 6 months, 9 months	Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances
Number of involuntary coughs per 24 hours	Baseline, 3 months, 6 months, 9 months	Patient reported, recorded by tally sheeting
Forced Expectoration	Baseline, 3 months, 6 months, 9 months	Patient reported, recorded by tally sheeting
Study-specific questionnaire to assess number of complications and medical treatments	Baseline, 3 months, 6 months, 9 months	Study specific questionnaire to record complications and consumption of medications, diagnostics, treatment, medical care, medical transportation, sick leave
Questionnaire to assess Shortness of Breath	Baseline, 3 months, 6 months, 9 months	from Ackerstaff et al., 1993
Voice handicap Index	Baseline, 3 months, 6 months, 9 months	patient reported outcome, score from 0-40, with higher scores indicating greater voice-related handicap.
Consumption of medical devices (Number of devices used)	Baseline, 3 months, 6 months, 9 months	Number of devices used, by use of patient diary recoding number of devices used

Trial Locations

Locations (1)

Instituto de Cancer Dr. Arnaldo; 🇧🇷 São Paulo, Brazil