Clinical trial NCT04943731: Day/Night Regimen With Provox Life Heat and Moisture Exchangers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngectomy
Keywords: Pulmonary rehabilitation
Heat and Moisture Exchangers
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: Princess Alexandra Hospital, Brisbane, Australia
name: Royal Brisbane and Women's Hospital
name: Prince of Wales Hospital, Sydney
First posted: 2021-06-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Multi-center, prospective, two-phase clinical study. The end of Phase 1 serves as the baseline for Phase 2.
Primary purpose: OTHER

Brief 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". 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in COUS score of CASA-Q
timeFrame: Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)
measure: Change COUI scores of CASA-Q
timeFrame: Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)
Secondary outcomes:
measure: Change in SPUS score of CASA-Q
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Change in SPUI score of CASA-Q
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Change in COUS scores of CASA-Q
timeFrame: Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
measure: Change in COUI scores of CASA-Q
timeFrame: Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks)
measure: Number of forced mucus expectorations per 24 hours
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Number of involuntary coughs per 24 hours
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Quality of Life by EQ-5D-5L
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Questionnaire for Skin Integrity
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Jenkins sleep evaluation questionnaire
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Questionnaire to assess Shortness of Breath
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Questionnaire to adjustment to Day/Night regimen
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Consumption of medical devices (Number of devices used)
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Study-specific questionnaire to assess number of complications and medical treatments
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
measure: Study-specific questionnaire to assess patients satisfaction
timeFrame: Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks)
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Prince of Wales Hospital, NSW
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
affiliation: Centre for functioning and Health Research, Metro South Hospital and Health Service
name: Elizabeth C Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.