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Completed

NCT Number: NCT04943731

Day/Night Regimen With Provox Life Heat and Moisture Exchangers

Purpose and Aim: This research is about patients who have had a total laryngectomy, trialing a new range of Heat and Moisture Exchangers (HMEs) - referred to as the "Provox Life™ range of HMEs". The main purpose of this study is to find out if participants experience any differences in the amount of coughing and mucus problems when using the new range of Provox Life™ HMEs (and attachment devices) following an optimal Day/Night regimen. The study is sponsored by Atos Medical.

Study Design: Participants will use the new Provox Life™ HME range and their attachments during two (2) observation phases (Phase 1, Phase 2). In Phase 1 (6 week study phase), participants will use the new Provox Life™ HMEs in a similar way as they currently use their existing HME devices. In the Phase 2 (6 week study phase), they will use the Provox Life™ HME devices following an optimal Day/Night regimen - with the aim to achieve the best possible humidification at all times. Prior to each study phase, participants will meet with their speech pathologist to learn about the new devices and how to use them. Once comfortable using them they will commence each observation phase.

Data Collection: Experiences using their existing HMEs (prior to study) and then using the new HMEs in Phase 1 and Phase 2 will be collected via a series of questionnaires. These will be completed 5 times in total - at baseline before Phase 1 starts, and then at both week 2 and week 6 of Phase 1 and 2. Questionnaires relate to their use of the HMEs, coughing and mucus problems, skin integrity, overall experiences of using the new devices and any impacts on sleep and quality of life. Participants will complete some of the questionnaires at home (approx. 30mins) and the others during an interview session with one of the study team (approx. 30mins). The interview session can be conducted via telephone, videoconferencing or in person - depending on the patients preferences and any COVID restrictions.

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Key information

Conditions

Laryngectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, NSW, Sydney, New South Wales, Australia

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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
  • HME user
  • Longer than 3 months after total laryngectomy
  • Longer than 6 weeks after postoperative radiotherapy

Exclusion criteria

  • Current day/night routine with Provox Luna
  • Daily use of Provox Micron HMEF
  • Medical problems prohibiting the use of HME
  • Active recurrent or metastatic disease (medical deterioration)
  • Recent pulmonary infections/unstable pulmonary condition
  • Reduced mobility of arms and/or hands, unable to insert or remove an HME
  • Unable to understand the Participant Information and/or unable to give Informed Consent
  • Insufficient cognitive ability to manage HME or adhesive use

Treatment and study plan

Provox Life

Device

Phase 1: Like for like transition, Phase 2: Provox Life day/night regimen

Primary outcomes

  1. Change in COUS score of CASA-Q

    Time frame: Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)

    Cough Symptoms (COUS) assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.

  2. Change COUI scores of CASA-Q

    Time frame: Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)

    Cough Impact (COUI) 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. Change in SPUS score of CASA-Q

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    Sputum Symptoms (SPUS) domains of the CASA-Q. Score between 0 and 100, with higher scores meaning less symptoms and less impact.

  2. Change in SPUI score of CASA-Q

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    Sputum Impact (SPUI) domains of the CASA-Q. Score between 0 and 100, with higher scores meaning less symptoms and less impact.

  3. Change in COUS scores of CASA-Q

    Time frame: Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)

    Cough Symptoms (COUS) assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.

  4. Change in COUI scores of CASA-Q

    Time frame: Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)

    CCough Impact (COUI) assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.

  5. Number of forced mucus expectorations per 24 hours

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    Patient reported, recorded by tally sheeting

  6. Number of involuntary coughs per 24 hours

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    Patient reported, recorded by tally sheeting

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

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    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 indicatinghigher health utility

  8. Questionnaire for Skin Integrity

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    Patient reported

  9. Jenkins sleep evaluation questionnaire

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances

  10. Questionnaire to assess Shortness of Breath

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    from Ackerstaff et al., 1993

  11. Questionnaire to adjustment to Day/Night regimen

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    Study specific questionnaire to describe patients adjustment to Day/Night regimen

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

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

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

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

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    Study specific questionnaire to record complications and consumption of medications, diagnostics, treatment, medical care, medical transportation, sick leave

  14. Study-specific questionnaire to assess patients satisfaction

    Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)

    patient satisfaction with devices and regimen

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Collaborators

  • Prince of Wales Hospital, Sydney
  • Princess Alexandra Hospital, Brisbane, Australia
  • Royal Brisbane and Women's Hospital

Registry information

Official study title

Changes in Pulmonary Outcomes as a Result of Implementing a Day and Night Regimen With Heat and Moisture Exchangers (HMEs) and Their Attachments

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2021
Registry last updated
May 15, 2023

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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