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Completed

NCT Number: NCT06084611

Long Term Effects of Heat and Moisture Exchangers (HMEs)

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

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Key information

Conditions

Laryngectomy; Status

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Cancer Dr. Arnaldo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Provox Life

Device

Compliant use of Provox Life HMEs

Primary outcomes

  1. CASA-Q Score

    Time frame: 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 outcomes

  1. Number of involuntary coughs per 24 hours

    Time frame: Baseline, 3 months, 6 months, 9 months

    Patient reported, recorded by tally sheeting

  2. Forced Expectoration

    Time frame: Baseline, 3 months, 6 months, 9 months

    Patient reported, recorded by tally sheeting

  3. Quality of Life by EQ-5D-5L

    Time frame: 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

  4. Jenkins sleep evaluation questionnaire

    Time frame: 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

  5. Questionnaire to assess Shortness of Breath

    Time frame: Baseline, 3 months, 6 months, 9 months

    from Ackerstaff et al., 1993

  6. Voice handicap Index

    Time frame: Baseline, 3 months, 6 months, 9 months

    patient reported outcome, score from 0-40, with higher scores indicating greater voice-related handicap.

  7. Consumption of medical devices (Number of devices used)

    Time frame: Baseline, 3 months, 6 months, 9 months

    Number of devices used, by use of patient diary recoding number of devices used

  8. Study-specific questionnaire to assess number of complications and medical treatments

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Collaborators

  • Instituto de Cancer Dr Arnaldo

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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