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Feasibility of a single-prong nasal cannula to deliver Nasal High Flow therapy in healthy volunteers

Feasibility of a single-prong nasal cannula to deliver Nasal High Flow therapy in healthy volunteers

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000458235
Enrollment
5
Registered
2018-03-29
Start date
2018-04-05
Completion date
2018-05-10
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This pilot study in healthy volunteers will assess the effect of Nasal High Flow therapy on ventilation in healthy adults with a modified single prong nasal cannula (Optiflow Uno) compared to a standard nasal cannula (Optiflow+). The purpose is to provide evidence and determine feasibility by assessing and gaining feedback on breathing physiology, noise level, and compliance/comfort/stability.

Interventions

Optiflow Uno - a single prong nasal interface to deliver Nasal High Flow The participant will spend two nights in the Sleep Lab. On one night the participant will receive the Optiflow Uno (intervention) and on the other night the Optiflow+ (control); the order that each device is received will be randomized. The AIRVO 2 will be used to generate the high flows and to heat and humidify the respiratory gas. The flows delivered via the Optiflow Uno will range between 0 to 30 L/min of heated and h

Optiflow Uno - a single prong nasal interface to deliver Nasal High Flow The participant will spend two nights in the Sleep Lab. On one night the participant will receive the Optiflow Uno (intervention) and on the other night the Optiflow+ (control); the order that each device is received will be randomized. The AIRVO 2 will be used to generate the high flows and to heat and humidify the respiratory gas. The flows delivered via the Optiflow Uno will range between 0 to 30 L/min of heated and humidified room air. There are two parts to the study; 1) changes in breathing in response to Nasal High Flow therapy during both wakefulness and sleep and 2) perception of the Nasal High Flow therapy as delivered by the device. Part 1: Breathing will be measured using respiratory inductance plethysmography during periods of receiving no therapy (baseline) and Nasal High Flow therapy (intervention) when awake and asleep. During sleep, breathing responses to Nasal High Flow therapy will be obtained during non-REM sleep. During part 1, breathing will be measured during different flow rates of Nasal High Flow (0 to 30 L/min); each flow rate will be applied for a maximum of 30 minutes at a time. Part 2: Once breathing responses are obtained, the flow rate of the Nasal High Flow will be set at the level that the subject went to sleep with, and is comfortable with, for the rest of the night. The subject is free to wake at any time and to remove the nasal interface at any time. At the time of waking the subject will be asked to fill in questionnaires and answer questions relating to the experience of the nasal interface. The study will be conducted in the Fisher and Paykel Sleep Lab located in Auckland, NZ and will be performed by Fisher and Paykel Healthcare Scientists

Sponsors

Fisher and Paykel Healthcare
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Between 18 and 40 years of age 2. Male 3. No diagnosis of sleep or respiratory conditions 4. Successfully passed a medical check-up for pre-existing sleep or respiratory conditions 5. Low score on the ‘Stop-Bang Sleep Apnoea Questionnaire’

Exclusion criteria

1) Under 18 years of age 2) Female 3) Existence of sleep or respiratory conditions such as sleep apnea and asthma or allergies

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026