Indukcja snów za pomocą EEG i znieczulenia w przypadku zespołu stresu pourazowego (IDEA_PTSD)

Inclusion Criteria:

A subject will be eligible for inclusion when all of the following criteria are met:

1. Male or female, 18 to 70 years of age
2. Able to read, understand, and provide written, dated informed consent prior to screening.
3. Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member and supported by the Quick Structured Clinical Interview for DSM Disorders (QuickSCID-5).
4. Meet the threshold of CAPS-5 score of >20 during screening.
5. Concurrent psychotherapy will be allowed if the type (e.g., supportive, cognitive behavioral, insight-oriented, et al) and frequency (e.g., weekly or monthly) of the therapy has been stable for at least 4 weeks prior to screening and if the type and frequency of the therapy is expected to remain stable during the course of the subject's participation in the study.
6. Concurrent antidepressant therapy (e.g. SSRI or SNRI) will be allowed if the therapy has been stable for at least 4 weeks prior to screening, and if it is expected to remain stable during the course of the subject's participation in the study.
7. In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I or II, or III. ASA Class III participants whose functional impairment is directly related to a psychiatric diagnosis (depression, anxiety or PTSD) will be included.
8. If female, a status of non-childbearing potential or use of an acceptable form of birth control
9. Body mass index between 17-35 kg/m2.

Exclusion Criteria:

A potential participant will NOT be eligible for participation if any of the following criteria are met:

1. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
2. Female who is pregnant or breastfeeding.
3. Female with a positive pregnancy test on the day of, and prior to, the anesthesia session.
4. Total CAPS-5 score ≤20 at either the screening.
5. Current diagnosis or a recent history (within 2 years) of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the QuickSCID-5, or Alcohol Use Disorder rated "moderate" or "severe" per QuickSCID-5 criteria. The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (>12 months) time frames.
6. History of schizophrenia or schizoaffective disorders, or a psychotic disorder as defined by QuickSCID-5 interview.
7. History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
8. Any DSM-5 Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening.
9. In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study.
10. A neurological disorder
11. A cardiovascular disorder
12. A pulmonary/respiratory disorder
13. Clinically significant liver disease
14. Clinically significant kidney disease
15. Symptomatic gastroesophageal reflux disease, hiatal hernia, or other gastrointestinal disorder placing patient at risk for aspiration or that would merit categorization of patient as ASA Class III or higher
16. An endocrine disorder
17. Any other abnormal laboratory result at the time of the screening exam that in the view of the investigator poses a risk for participation in the study.
18. Has abnormality on the screening physical examination that might affect safety, study participation or confound interpretation of study results, including any condition that would merit categorization of patient as ASA Class III or higher.
19. Has a positive urine drug screen on the day of the anesthesia session.
20. If, in the view of the participant's current primary mental health care provider this study poses a risk for participation (if a participant has a current mental health care provider).
21. Participation in any clinical trial with an investigational drug or device that conflicts with this trial, within the past month or concurrent to study participation.