Assessment of Sleep Quality in Cannabinoid Therapy

Cerebra Medical

Status: Enrolling

Conditions: Poor Sleep Quality

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05237037

Ekosi

Details and patient eligibility

About

The current study aims to assess the impact of starting cannabinoid therapy on sleep quality for individuals with sleep disturbance.

Full description

After the initial signing of the consent form, they will complete a battery of baseline questionnaires online on sleep, including the Sleep Regularity Questionnaire, Epworth Sleepiness Scale, Insomnia Severity Index, and the Depression, Anxiety, Stress Scale (DASS-21). That night, before beginning active treatment, participants will be monitored using Cerebra's Level 2 plus ECG system (the Prodigy).

After 6 weeks of active treatment, participants will again complete a night of Level 2 plus ECG recording using the Prodigy, evening, and morning questionnaires, and will repeat baseline sleep questionnaires.

Enrollment: 34 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. A Pittsburgh Sleep Quality Index score >5
2. Between the ages of 40-65
3. No current recreational or medical cannabis use within 4 weeks of the study initiation OR positive urine drug screen (UDS) for Tetrahydrocannabinol
4. No use of anti-psychotics, tricyclic antidepressants, or prescription stimulants
5. No use of medications for promoting sleep (e.g., anti-histamines, benzodiazepines, melatonin).
6. Low risk of Obstructive Sleep Apnea (Low Risk on Berlin Questionnaire), or no presence of moderate or severe Obstructive Sleep Apnea on baseline polysomnography (AHI <15).
7. Has been prescribed THC:CBD combination therapy