LaryngectomyNCT04943731
Day/Night Regimen With Provox Life Heat and Moisture Exchangers
A study testing Provox Life in people with Laryngectomy, run by Atos Medical AB at 3 sites in Australia.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy
- What is being tested?
- Provox Life
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesAustralia
- Study dates
- 26 Jul 2021to 4 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Prince of Wales Hospital, NSW
Sydney, New South Wales, 2031
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official title: Changes in Pulmonary Outcomes as a Result of Implementing a Day and Night Regimen With Heat and Moisture Exchangers (HMEs) and Their Attachments
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.
- Conditions
- Laryngectomy
- Being tested
- Provox Life
- Keywords
- Pulmonary rehabilitation, Heat and Moisture Exchangers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provox LifeDevice
Phase 1: Like for like transition, Phase 2: Provox Life day/night regimen
| Study group | Role | What they receive |
|---|---|---|
| Provox Life™ | Other | Phase 1: Provox Life™. Like-for-like transition from Provox (or other brand) to Provox Life™ under guidance from Speech Pathologist who will assess when the participant is ready to commence the 6 week study observation period.
Phase 2: Provox Life™ with Day/Night regimen. Establishment of optimal day/night routine under guidance of Speech Pathologist who will assess when the participant is ready to commence the 6 week observation period. Receives: Device: Provox Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COUS score of CASA-Q
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.
Measured: Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)
Change COUI scores of CASA-Q
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.
Measured: Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)
Secondary outcomes (14)
Change in SPUS score of CASA-Q
Sputum Symptoms (SPUS) domains of the CASA-Q. Score between 0 and 100, with higher scores meaning less symptoms and less impact.
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Change in SPUI score of CASA-Q
Sputum Impact (SPUI) domains of the CASA-Q. Score between 0 and 100, with higher scores meaning less symptoms and less impact.
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Change in COUS scores of CASA-Q
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.
Measured: Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
Change in COUI scores of CASA-Q
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.
Measured: Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
Number of forced mucus expectorations per 24 hours
Patient reported, recorded by tally sheeting
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Number of involuntary coughs per 24 hours
Patient reported, recorded by tally sheeting
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
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 indicatinghigher health utility
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Questionnaire for Skin Integrity
Patient reported
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Jenkins sleep evaluation questionnaire
Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Questionnaire to assess Shortness of Breath
from Ackerstaff et al., 1993
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Questionnaire to adjustment to Day/Night regimen
Study specific questionnaire to describe patients adjustment to Day/Night regimen
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Consumption of medical devices (Number of devices used)
Number of devices used, by use of patient diary recoding number of devices used
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
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
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Study-specific questionnaire to assess patients satisfaction
patient satisfaction with devices and regimen
Measured: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start26 Jul 2021
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaryngectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Multi-center, prospective, two-phase clinical study. The end of Phase 1 serves as the baseline for Phase 2.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atos Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princess Alexandra Hospital, Brisbane, Australia, Royal Brisbane and Women's Hospital, Prince of Wales Hospital, Sydney
- Responsible party
- Sponsor
- Investigators
- Elizabeth C Ward, PhD, Principal investigator, Centre for functioning and Health Research, Metro South Hospital and Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943731
- Sponsor's protocol ID
- HREC/2021/QMS/74792
- Status last verified
- May 2023
- First submitted
- 7 Jun 2021
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ward EC, Hancock K, Boxall J, Burns CL, Spurgin AL, Lehn B, Hoey J, Robinson R, Coleman A. Post-laryngectomy pulmonary and related symptom changes following adoption of an optimal day-and-night heat and moisture exchanger (HME) regimen. Head Neck. 2023 Apr;45(4):939-951. doi: 10.1002/hed.27323. Epub 2023 Feb 20.
PubMed 36808179
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pulmonary Outcomes as a Result of Implementing a Day and Night Regimen With Heat and Moisture Exchangers (HMEs) and Their Attachments
- ClinicalTrials.gov ID
- NCT04943731
- Acronym / sponsor ID
- HREC/2021/QMS/74792
- Conditions
- Laryngectomy
- Keywords
- Pulmonary rehabilitation, Heat and Moisture Exchangers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Atos Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- Princess Alexandra Hospital, Brisbane, Australia, Royal Brisbane and Women's Hospital, Prince of Wales Hospital, Sydney
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-center, prospective, two-phase clinical study. The end of Phase 1 serves as the baseline for Phase 2.
| Arm | Type | Receives |
|---|---|---|
| Provox Life™ | Other | Device: Provox LifePhase 1: Provox Life™. Like-for-like transition from Provox (or other brand) to Provox Life™ under guidance from Speech Pathologist who will assess when the participant is ready to commence the 6 week study observation period. Phase 2: Provox Life™ with Day/Night regimen. Establishment of optimal day/night routine under guidance of Speech Pathologist who will assess when the participant is ready to commence the 6 week observation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provox LifePhase 1: Like for like transition, Phase 2: Provox Life day/night regimen | Device | Provox Life™ |
Primary outcome
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.
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.
14 secondary outcomes
Change in SPUS score of CASA-Q
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Change in SPUI score of CASA-Q
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Change in COUS scores of CASA-Q
Time frame: Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
Change in COUI scores of CASA-Q
Time frame: Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
Number of forced mucus expectorations per 24 hours
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Number of involuntary coughs per 24 hours
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Quality of Life by EQ-5D-5L
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Questionnaire for Skin Integrity
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Jenkins sleep evaluation questionnaire
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Questionnaire to assess Shortness of Breath
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Questionnaire to adjustment to Day/Night regimen
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Consumption of medical devices (Number of devices used)
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
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 assess patients satisfaction
Time frame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Results publication: PubMed 36808179Ward EC, Hancock K, Boxall J, Burns CL, Spurgin AL, Lehn B, Hoey J, Robinson R, Coleman A. Post-laryngectomy pulmonary and related symptom changes following adoption of an optimal day-and-night heat and moisture exchanger (HME) regimen. Head Neck. 2023 Apr;45(4):939-951. doi: 10.1002/hed.27323. Epub 2023 Feb 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth C Ward, PhD principal investigator
Centre for functioning and Health Research, Metro South Hospital and Health Service
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provox Life in people with Laryngectomy, run by Atos Medical AB at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COUS score of CASA-Q (time frame: Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.