Intranasal Temperature Modulation Device in Awake Healthy Volunteers: A First In-Human Safety and Tolerability Study.

Area of Science:

• Neurology
• Biomedical Engineering
• Critical Care Medicine

Background:

• Fever post-brain injury worsens outcomes.
• Current temperature-modulating devices (TMDs) have significant limitations including invasiveness, delayed deployment, and need for sedation.
• These limitations hinder timely neuroprotection and complicate assessments.

Purpose of the Study:

• Evaluate the safety and tolerability of a novel intranasal TMD.
• Assess the efficacy of intranasal cooling in reducing core body temperature.
• Determine if the intranasal TMD avoids common side effects like shivering and the need for sedation.

Main Methods:

• First-in-human study involving five healthy, awake adult volunteers.
• Intranasal cooling using 5°C air delivered via nasal cannula at varying flow rates.
• Core body temperature monitored with an esophageal probe.
• Safety and tolerability assessed as primary endpoints; no sedatives or pharmacological agents used.

Main Results:

• Consistent reduction in core body temperature observed, averaging 0.7°C at 30 minutes and 1.2°C at 60 minutes.
• No shivering or adverse events were reported.
• The device was well-tolerated, with participants remaining conscious and communicative.

Conclusions:

• The intranasal TMD achieved clinically relevant core cooling safely and effectively in healthy volunteers.
• This device overcomes key barriers of traditional TMDs, offering a potential neuroprotective therapy.
• Further investigation in patients with acute neurological injury and in critical care settings is warranted.