Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT03735004
Eligibility Criteria:
Inclusion Criteria: Patients with moderate-to-severe OSA, presenting for PPP and MMA surgeries. All patients will be American Society of Anesthesiology (ASA) physical status II-III. The subjects should understand informed consent and study instructions.
Exclusion Criteria:
1. Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Sevoflurane, an inhaled anesthetic agent.
2. Pregnant patients.
3. Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores, or to keep home diaries.
4. Patients with clinically-significant psychological disorders, psychiatric illness or treatment.
5. Alcohol and drug-abusing patients.
6. Patients with the history of seizures.
7. Patients with the documented or suspected organic brain or psychiatric disease, in particular with the history of hallucinations and delusions.
8. Patients with history of significant eye disease, or head or eye injury, which led to alteration of the cranial anatomy or metallic intracranial implants.
9. Patients with the history of significant surgery of the head and/or eye.
10. Patients with skin lesions and/or defects over the areas where TES electrodes will be applied.
11. Patients with implanted medical devices, including cardiac pacemakers.
12. Patients who participate in other research protocols that may interfere with the study outcomes and objectives.
13. Other patients that may be excluded by the investigator, based on medical history and physical examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03735004
Study Brief:
Protocol Section:
NCT03735004