None listed
Conditions
Brief summary
Allergic rhinitis (AR) and chronic rhinosinusitis (CRS) are significant global health issues, affecting many people in New Zealand. They can cause symptoms like nasal congestion, runny nose, and sleep disturbances. Current treatments, such as antihistamines and nasal sprays, offer temporary relief but can have side effects with long-term use. The human body hosts numerous microorganisms, known as the microbiota, which play a vital role in health. Research shows that the nasal microbiota differs between healthy individuals and those with respiratory diseases. A diverse microbiota supports a balanced immune response, while an imbalance can increase susceptibility to infections. The Goodair® NoseBuds is a device that creates vibrations in the nose to mimic humming, which has been beneficial for patients with CRS. Studies indicate that it can improve symptoms and increase nitric oxide levels in the nasal passages, potentially aiding in the treatment of both AR and CRS without the risks of long-term medication use. This study aims to explore how acoustic therapy influences the nasal microbiome, immune responses, and overall well-being of individuals with AR and CRS. By validating acoustic therapy as an effective treatment option, the study could lead to safer, non-pharmaceutical strategies for managing respiratory conditions, ultimately improving patient outcomes and quality of life.
Interventions
The principal aims of the study are to investigate the effects of acoustic therapy using the Goodair Nosebuds on the nasal microbiome, immune markers, and overall well-being in individuals with allergic rhinitis (AR) and chronic rhinosinusitis (CRS). The Goodair Nosebuds is a portable device that participants can insert into their nose to provide acoustic therapy in the form of augmented humming at 130 Hz. In the pre-treatment visit (Clinic Visit 1), participants will be shown how to use the dev
The principal aims of the study are to investigate the effects of acoustic therapy using the Goodair Nosebuds on the nasal microbiome, immune markers, and overall well-being in individuals with allergic rhinitis (AR) and chronic rhinosinusitis (CRS). The Goodair Nosebuds is a portable device that participants can insert into their nose to provide acoustic therapy in the form of augmented humming at 130 Hz. In the pre-treatment visit (Clinic Visit 1), participants will be shown how to use the device by a Clinical Investigator with over 20 years experience as an Ear-Nose-Throat surgeon. Participants will then be asked to used the device for 10 minutes, twice daily for about 4 weeks, in their own homes (the intervention). A member of the research team will check in weekly with the participants during this time by email or phone. A self-reported adherence to the intervention will be obtained in the post-treatment visit (Clinic Visit 2) as part of a user-experience questionnaire. As the participants will be able to keep the device, their voluntary continuation with the intervention will also be obtained through the user-experience questionnaire in the Follow up visit (Clinic Visit 3). Participants will attend three clinic visits: one at the beginning (pre-treatment) and one after using the acoustic therapy device for four weeks (post-treatment), each lasting up to one hour. A follow-up visit will occur several weeks after the main study to assess longer-term effects. There will be no randomisation or blinding, and the study will not include a control group, as comparisons will be made to the pre-treatment datapoint for each individual.
Sponsors
Auckland University of Technology
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 to 80 years old 2. Symptoms of CRS or AR 3. Non-smoker
Exclusion criteria
1. Fixed structural cause of nasal congestion 2. Current nasal crusting or ulceration on rhinoscopy 3. History of severe nose bleeding within last 3 months 4. Anticoagulation use (acetylsalicylic acid allowed), 5. Known pregnancy 6. Allergic sensitivity to silicone or any other component of device 7. Inability to read and understand English 8. Inability to perform treatment due to underlying medical condition. 9. Nasal swab taken within the past seven days- clinic visits can be re-scheduled for a later date. 10. History of immune disorders or chronic inflammatory diseases other than CRS or AR.
Outcome results
None listed