Laryngectomy; StatusNCT06084611
Long Term Effects of Heat and Moisture Exchangers (HMEs)
A study testing Provox Life in people with Laryngectomy; Status, run by Atos Medical AB at 1 site in Brazil.
Trial summary
Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy; Status
- 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
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Mar 2024to 30 Sep 2025
- 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
- Longer than 3 months after total laryngectomy
- Longer than 6 weeks after postoperative radiotherapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Effects of Heat and Moisture Exchangers (HMEs) (Provox® Life™) on Pulmonary Symptoms in Laryngectomized Patients
Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.
- Conditions
- Laryngectomy; Status
- Being tested
- Provox Life
- Keywords
- Laryngectomy, Heat and Moisture Exchanger, HME, Pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provox LifeDevice
Compliant use of Provox Life HMEs
| Study group | Role | What they receive |
|---|---|---|
| Provox Life HME | Experimental | Use of Provox Life HMEs and attachment Receives: Device: Provox Life |
| Control - No HME | No intervention | Control group is current standard of Care in Brazil, which is not using an HME |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 9 months
Secondary outcomes (8)
Number of involuntary coughs per 24 hours
Patient reported, recorded by tally sheeting
Measured: Baseline, 3 months, 6 months, 9 months
Forced Expectoration
Patient reported, recorded by tally sheeting
Measured: Baseline, 3 months, 6 months, 9 months
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
Measured: Baseline, 3 months, 6 months, 9 months
Jenkins sleep evaluation questionnaire
Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances
Measured: Baseline, 3 months, 6 months, 9 months
Questionnaire to assess Shortness of Breath
from Ackerstaff et al., 1993
Measured: Baseline, 3 months, 6 months, 9 months
Voice handicap Index
patient reported outcome, score from 0-40, with higher scores indicating greater voice-related handicap.
Measured: Baseline, 3 months, 6 months, 9 months
Consumption of medical devices (Number of devices used)
Number of devices used, by use of patient diary recoding number of devices used
Measured: Baseline, 3 months, 6 months, 9 months
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, 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start26 Mar 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
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 Laryngectomy; StatusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atos Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto de Cancer Dr Arnaldo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084611
- Sponsor's protocol ID
- PL_Brazil
- Status last verified
- Sep 2025
- First submitted
- 10 Oct 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Cicco R, de Souza RP, Moreira CGS, Calcines SL, Vieira VB, Marquezin DMSS, Nakai MY, Menezes MB, Milan TB, Dias FA. Provox Life HMEs for Pulmonary Rehabilitation in HME-Naive Laryngectomy Patients: A Randomized Controlled Trial. Laryngoscope Investig Otolaryngol. 2026 Sep 27;11(5):e70576. doi: 10.1002/lio2.70576. eCollection 2026 Oct.
PubMed 42802786
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Heat and Moisture Exchangers (HMEs) (Provox® Life™) on Pulmonary Symptoms in Laryngectomized Patients
- ClinicalTrials.gov ID
- NCT06084611
- Acronym / sponsor ID
- PL_Brazil
- Conditions
- Laryngectomy; Status
- Keywords
- Laryngectomy, Heat and Moisture Exchanger, HME, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Atos Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- Instituto de Cancer Dr Arnaldo
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 16 Oct 2023 (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.
Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Provox Life HME | Experimental | Device: Provox LifeUse of Provox Life HMEs and attachment |
| Control - No HME | No intervention | –Control group is current standard of Care in Brazil, which is not using an HME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 LifeCompliant use of Provox Life HMEs | Device | Provox Life HME |
Primary outcome
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.
8 secondary outcomes
Number of involuntary coughs per 24 hours
Time frame: Baseline, 3 months, 6 months, 9 months
Forced Expectoration
Time frame: Baseline, 3 months, 6 months, 9 months
Quality of Life by EQ-5D-5L
Time frame: Baseline, 3 months, 6 months, 9 months
Jenkins sleep evaluation questionnaire
Time frame: Baseline, 3 months, 6 months, 9 months
Questionnaire to assess Shortness of Breath
Time frame: Baseline, 3 months, 6 months, 9 months
Voice handicap Index
Time frame: Baseline, 3 months, 6 months, 9 months
Consumption of medical devices (Number of devices used)
Time frame: Baseline, 3 months, 6 months, 9 months
Study-specific questionnaire to assess number of complications and medical treatments
Time frame: Baseline, 3 months, 6 months, 9 months
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 3 Oct 2025.
- Derived from this study: PubMed 42802786De Cicco R, de Souza RP, Moreira CGS, Calcines SL, Vieira VB, Marquezin DMSS, Nakai MY, Menezes MB, Milan TB, Dias FA. Provox Life HMEs for Pulmonary Rehabilitation in HME-Naive Laryngectomy Patients: A Randomized Controlled Trial. Laryngoscope Investig Otolaryngol. 2026 Sep 27;11(5):e70576. doi: 10.1002/lio2.70576. eCollection 2026 Oct.
- Individual participant dataSharing planned: No
Related trials for Laryngectomy; Status
RecruitingObservational study
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
Speech Disorders, Speech Dysfunction
RecruitingObservational study
Workshops and Exchange Groups for Laryngectomized Patients
Laryngectomy; Status, Laryngeal Cancer
RecruitingPhase 2
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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; Status, run by Atos Medical AB at 1 site in Brazil.
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 4 inclusion and 7 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
CASA-Q Score (time frame: Baseline, 3 months, 6 months, 9 months). 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 NCT06084611, 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 3 Oct 2025.