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 operates in two modes: one produces a vibration that mimics humming in both nostrils, and the other alternates between the right and left 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: Augmented breathing with vibroacoustic stimulation, a small, wearable device that fits onto the nose to deliver mechanostimulation to the nasal airway mucosa during breathing.
Modes of Operation: The device has two modes:
1) Breeze Mode: Provides humming stimulation to both sides of the nose without airflow regulation.
2) Relax Mode: Applies lateralized humming and airflow regulation that alternates between each side of the nose every 3 minutes.
In the main study, participants (n=60) wi
Device: Augmented breathing with vibroacoustic stimulation, a small, wearable device that fits onto the nose to deliver mechanostimulation to the nasal airway mucosa during breathing. Modes of Operation: The device has two modes: 1) Breeze Mode: Provides humming stimulation to both sides of the nose without airflow regulation. 2) Relax Mode: Applies lateralized humming and airflow regulation that alternates between each side of the nose every 3 minutes. In the main study, participants (n=60) will use the Nosebuds (Breeze or relax mode) for 12 minutes, twice daily, over a 2-week period. There will be two separate intervention groups, each assigned to a different mode of the Nosebuds. One group will use the Breeze (Decongestion) mode, while the other group will exclusively use the Relax (De-stress) mode throughout the study. This approach allows for a direct comparison of the effects of each mode on the participants. The timing for device use is 12 minutes because the cycling mode of the device requires 3 minutes per cycle. Therefore, to complete two cycles, each lasting 3 minutes, the total duration sums up to 12 minutes. b) Usage Timing: Participants are instructed to use the Nosebuds twice daily for 12 minutes each session. The specific timing within the day isn’t rigid; participants can choose when to use the device. c) Position During Use: The Nosebuds can be used while sitting or lying down, but there is no requirement to be in a specific position during usage. Participants are encouraged to be comfortable while using the device. d) Adherence Monitoring: Adherence to the intervention will be assessed primarily through self-reporting, where participants may maintain a diary to log their daily usage.
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