Blood pressure and comfort with transcutaneous hypoglossal nerve stimulation using the Zeus Sleep Device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses the Zeus Sleep Device to deliver transcutaneous hypoglossal nerve stimulation during sleep in healthy adults. The goal is to characterize any effects on blood pressure while assessing tolerability and safety in a population without obstructive sleep apnea. Participants will have device placement under the chin and will be monitored for cardiovascular and safety outcomes. The trial focuses on short-term exposure and includes clear exclusion criteria to minimize risk. Results will inform whether this approach can be pursued in patients with sleep-disordered breathing without adversely impacting blood pressure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 18 or older
2. Either biological sex
3. Healthy volunteers
4. Able to provide informed consent
5. No contraindications to hypoglossal nerve stimulation using the Zeus device
6. BMI \>18.5 and \<30kg/m2

Exclusion Criteria:

1. Skin allergy, including eczema or allergic contact dermatitis in device placement area
2. Diagnosed heart condition or cardiovascular disease
3. Cardiovascular event in the previous 2 months
4. Implanted medical devices including cardioverter defibrillator and pacemaker
5. Previous or current cardiac arrhythmia
6. Autonomic neuropathy
7. Neuromuscular disease
8. Diagnosed epilepsy or recurrent seizures
9. Hypertension (\>140/90 mmHg)
10. Hypotension (\<95/65 mmHg)
11. Metal work in the head or neck, excluding dental fillings
12. Current migraine
13. Pregnancy
14. Diagnosed or suspected deep vein thrombosis within previous 2 months
15. Recent cancer diagnosis or cancerous legions in proximity to device placement area
16. Alcohol dependence
17. Recent infection requiring hospital admission or medical treatment within the previous month, including leprosy
18. Swollen, inflamed, infected, or broken skin in device placement area
19. Recent surgery within 10 months in, or near, device placement area
20. Currently taking medications, excluding contraceptive medication
21. Long facial hair in device placement area

Where it's running

• Royal Brompton Hospital
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Abigail Smart
• Email: abigail.smart@nhs.net
• Phone: 020 7351 8910

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.