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Assessment of Sleep Quality in Cannabinoid Therapy

Assessment of Sleep Quality in Patients Utilizing Cannabinoid Therapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05237037
Enrollment
34
Registered
2022-02-11
Start date
2022-08-22
Completion date
2023-08-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Sleep Quality

Keywords

Cannabinoid Therapy

Brief summary

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

Detailed 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.

Interventions

None listed

Sponsors

Ekosi Health Centre
CollaboratorUNKNOWN
Cerebra Medical
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in Sleep Quality (Pittsburgh Sleep Quality Index)6 weeks
Change in Objective Sleep Quality (Odds Ratio Product)6 weeks

Countries

Canada

Contacts

Primary ContactShelley Turner, MD
sturner@ekosihealth.com866-370-8388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026