Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia

Eligibility criteria

By adhering to the following criteria, the study aims to select a population that can safely undergo the PROSOMNIA Sleep therapy and for whom the therapy is most likely to be beneficial, ensuring the reliability and validity of the study outcomes.
INCLUSION CRITERIA:
1. Age Range: 18-65 years of age Reason: This age range includes adults who are most likely to benefit from the PROSOMNIA Sleep therapy and who can provide informed consent. It also excludes children and older adults who may have different physiological responses or additional health risks.
2. Diagnosed or Undiagnosed Chronic Insomnia:
   Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.
3. Diagnosed or Undiagnosed Sleep Deprivation:
   Reason: Includes individuals who are not getting enough sleep quantity, which is a key condition that the PROSOMNIA Sleep Therapy aims to address.
4. Diagnosed or Undiagnosed REM Sleep Inconsistencies:
   Reason: Includes individuals who are not getting enough sleep quality and those with specific REM sleep phase issues that the PROSOMNIA Sleep Therapy is designed to improve.
5. Failure to Respond to Conventional Sleep Treatments:
   Reason: Focuses on subjects who have not found relief from existing sleep therapies, ensuring that the study population represents those in need of alternative solutions.
6. Ability to Provide Informed Consent:
Reason: Ensures that participants understand the study and agree to participate voluntarily.
EXCLUSION CRITERIA:
1. Severe Obesity (BMI \> 40):
   Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.
2. Cardiovascular Conditions:
   Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.
3. Neurological Disorders:
   Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.
4. Other Health Conditions Contraindicating Anesthesia:
   Reason: Includes any condition that would make the use of anesthesia unsafe.
5. Greater than ASA II Status:
   Reason: The American Society of Anesthesiologists (ASA) physical status classification system classifies patients based on their pre-anesthesia medical conditions. Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.
6. Current Use of Prohibited Medications:
   Reason: Medications that could interfere with the combined use of anesthesia including, but not limited to sedatives and hypnotics; such as benzodiazepines, Z-drugs and barbiturates.
7. Pregnancy or Breastfeeding:
Reason: Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-05-28