None listed
Conditions
Brief summary
The aim of this study is to find out if rhinothermy (the nasal delivery of warm, humidified air) with the air heated to 45 degrees Celsius is safe and comfortable. It has been proposed that rhinothermy may improve cold and flu symptoms, by stopping the multiplication of the viruses that cause these symptoms. These viruses may require different temperatures to stop multiplication. Previous research has shown that rhinothermy at 41 degrees Celsius is tolerable, however tolerability at 45 degrees has not yet been assessed. In order to undertake future studies to see if rhinothermy at 45 degrees can help decrease the burden of cold and flu symptoms, we need to see that it is both safe and comfortable to use. We aim to recruit 20 healthy participants between the ages of 18 and 75 years, who will attend the Medical Research Insitute of New Zealand for up to three visits and be randomised to one of two groups. One group will receive 60 minutes of rhinothermy at 41 degree Celsius, and the other at 45 degree Celsius. Participants will be able to stop the intervention at any time, which will be recorded. After the intervention, they will be asked to rate how comfortable they found it and indicated any reasons for stopping the treatment early. Following the completion of the study, the proportion of participants in each group who found the intervention tolerable will be calculated and compared, along with any reported adverse events, the length of time tolerated in each group, response to individual tolerability questions and the reasons for stopping the intervention early.
Interventions
Three visits per subject (visits one and two may be combined at the subject request). Visits will be undertaken in person at the Medical Research Institute of New Zealand. Participants will be shown the device and the nasal cannula that is used for delivery of the intervention. They will be given the option of placing the nasal cannula on themselves or requesting the study investigator or co-ordinator to place it. All MRINZ staff delivering the intervention will be trained in device operation
Three visits per subject (visits one and two may be combined at the subject request). Visits will be undertaken in person at the Medical Research Institute of New Zealand. Participants will be shown the device and the nasal cannula that is used for delivery of the intervention. They will be given the option of placing the nasal cannula on themselves or requesting the study investigator or co-ordinator to place it. All MRINZ staff delivering the intervention will be trained in device operation. During the course of the intervention a study investigator will be present observing the participant to ensure that the cannula are placed correctly and to monitor the device to ensure it is working correctly. Participants will be randomised 1:1 to one of two groups, intervention or comparator. Intervention: One continuous session of rhinothermy (rNHF) with 100% humidified air delivered via the rNHF (Fisher & Paykel AIRVO 3) device at 35L/min at 41o Celsius (C) for sixty minutes The intervention may be stopped at any time by the participant. An outline of the visits and interventions are supplied below: Visit 1: 1. Written informed consent with collection of demographic data, medical and surgical history, concomitant medications and allergies, vital signs (heart rate, blood pressure, oxygen saturation and temperature) and a limited physical examination (chest, nose and throat). 2. Assessment for eligibility Visit 2 (may be at the same time as Visit 1): 1. Reassessment of eligibility criteria and re-examination of the nose and throat prior to randomisation (ONLY if Visit 2 on a separate day to Visit 1). 2. Randomisation to Intervention or Comparator. 3. Delivery of Intervention or Comparator for a period of sixty minutes. 4. Questionnaire indicating reason for stopping intervention or comparator prior to sixty minutes (if applicable) 5. Questionnaire indicating tolerability of intervention and comparator. 6. Post-intervention/comparator examination of the nose and throat. Visit 3: 1. Examination of the nose and throat. 2. Review for any adverse events.
Sponsors
Fisher & Paykel Healthcare Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Twenty healthy participants aged 18 to 75 years who are in the Investigator’s opinion, able and willing to comply with all study requirements. Two weeks post full vaccination against SARS-CoV-2 (COVID-19); may either be New Zealand based COMINARTY (Pfizer BioNTech) or administration of equivalent vaccination
Exclusion criteria
Upper respiratory tract infection (sore throat, cough, rhinorrhoea and/or fever (subjective of objective) within the last fourteen days Chronic respiratory illness currently being treated e.g. asthma Nasopharyngeal conditions such as a deviated septum and acute/chronic rhinitis, which the investigator considers could impair nasal breathing Use of nasal sprays within the last seven days Current smoker, defined as someone who has smoked or vaped within the last 28 days Current use of or requirement of oral antibiotics for a respiratory tract infection, pneumonia or infective exacerbation of an underlying respiratory condition Current use of or requirement of parenteral antibiotics Have an implantable medical device Have any other condition which, at the investigator’s discretion, is believed may present a safety risk to the participant or others, or impact the study results or the feasibility of the study. Previous enrolment in any trials investigating the use of rhinothermy.
Outcome results
None listed