None listed
Conditions
Brief summary
Sleep, breathing, and mental health are closely linked. This study aims to assess and compare the acute (immediate) effects of two augmented breathing devices on the brain activity using an electroencephalogram (EEG), and on the autonomic (fight/flight vs.rest and digest) nervous system using variability in heart rate, changes in conductivity of skin, and speed of breathing. It will also look at the longitudinal (longer-term) effect of using these devices on sleep, using a FitBit wearable, and on perceptions of depression, anxiety, and stress using questionnaires. The devices, called "nosebuds," are designed to be worn in the nostrils and induce a vibration that mimics humming, which can promote a calmer state and alter brain activity. One device vibrates both nostrils simultaneously, while the other alternates vibrations between the right and left nostril. The hypothesis of this study is that the Goodair Nosebuds can reduce stress, anxiety, and depression by improving autonomic nervous system regulation. The device produces a vibration that mimics humming in both nostrils. It is expected that regular use of either mode will help participants achieve better autonomic balance, potentially reducing symptoms of stress and improving mood. This may be evidenced by changes in brain activity, heart function, breathing, and skin response, all of which are linked to stress response and overall mental well-being
Interventions
Device: Goodair Nosebuds – a small, wearable device that fits onto the nose and delivers mechanostimulation to the nasal airway mucosa during breathing.
Modes of Operation:
For this study, only one active mode will be used:
Breeze Mode: Delivers non-lateralized humming stimulation to both nasal passages without airflow regulation. This mode is designed to support decongestion and relaxation by gently vibrating both sides of the nose simultaneously.
Intervention Protocol:
Duration: 2 weeks
Device: Goodair Nosebuds – a small, wearable device that fits onto the nose and delivers mechanostimulation to the nasal airway mucosa during breathing. Modes of Operation: For this study, only one active mode will be used: Breeze Mode: Delivers non-lateralized humming stimulation to both nasal passages without airflow regulation. This mode is designed to support decongestion and relaxation by gently vibrating both sides of the nose simultaneously. Intervention Protocol: Duration: 2 weeks Frequency: Participants will use the device twice daily, 12 minutes per session Total Number of Participants: 16 Group Assignment: Active Group (n = 8): Uses the Breeze Mode Nosebuds Sham Group (n = 8): Uses the non-stimulating sham device Usage Instructions: Timing: Participants may choose when to use the device each day; no strict schedule is imposed. Posture: Device may be used while sitting or lying down; participants are encouraged to be in a comfortable position. Adherence Monitoring: Participants will maintain a daily usage log (self-reported diary) to monitor compliance with the intervention protocol.
Sponsors
New Zealand College of Chiropractic
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years and older who self-report pre-clinical stress, anxiety, depression, or sleep issues and score 'mild' or 'moderate' on the DASS-21 or PSQI questionnaires are eligible for inclusion.
Exclusion criteria
Exclusion criteria include individuals with a recent upper airway or sinus infection, a history of mental illness, respiratory conditions (except mild, well-controlled asthma), noticeable septum deviation or perforation, and allergies. Current smokers (including those who smoke cigarettes, vape, or use any form of smoking), as well as individuals who have quit smoking in the past five years or have used any form of tobacco or recreational drugs within the last three months, will also be excluded. Additionally, individuals with chronic conditions such as heart disease, cardiovascular disease, metabolic diseases (including diabetes), disorders of the autonomic nervous system, or any diagnosed neurological conditions are not eligible. Participants with noticeable septum deviation, perforation, or abnormal nasal mucosa will be excluded. Furthermore, individuals scoring 'normal,' 'severe,' or 'very severe' on the DASS-21 or PSQI questionnaires will not be eligible.
Outcome results
None listed