Assessment of Sleep Quality in Cannabinoid Therapy
1 other identifier
observational
34
1 country
1
Brief Summary
The current study aims to assess the impact of starting cannabinoid therapy on sleep quality for individuals with sleep disturbance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
August 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFebruary 8, 2023
February 1, 2023
11 months
February 2, 2022
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
6 weeks
Change in Objective Sleep Quality (Odds Ratio Product)
6 weeks
Eligibility Criteria
Patients who have completed standard clinic intake and medical screening at Ekosi Health and been deemed appropriate for a combination THC:CBD treatment will be screened for study participation.
You may qualify if:
- A Pittsburgh Sleep Quality Index score \>5
- Between the ages of 40-65
- No current recreational or medical cannabis use within 4 weeks of the study initiation OR positive urine drug screen (UDS) for Tetrahydrocannabinol
- No use of anti-psychotics, tricyclic antidepressants, or prescription stimulants
- No use of medications for promoting sleep (e.g., anti-histamines, benzodiazepines, melatonin).
- 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).
- Has been prescribed THC:CBD combination therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cerebra Medicallead
- Ekosi Health Centrecollaborator
Study Sites (1)
Ekosi Health Centre
Winnipeg, Manitoba, R3A 0J5, Canada
Related Publications (4)
Dzierzewski JM, Donovan EK, Sabet SM. The Sleep Regularity Questionnaire: development and initial validation. Sleep Med. 2021 Sep;85:45-53. doi: 10.1016/j.sleep.2021.06.028. Epub 2021 Jun 28.
PMID: 34274811BACKGROUNDJohns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PMID: 1798888BACKGROUNDMorin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
PMID: 21532953BACKGROUNDLovibond, S.H., & Lovibond, P.F. Manual for the Depression Anxiety Stress Scales. (2nd Ed.) Sydney: Psychology Foundation. (1995).
BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2022
First Posted
February 11, 2022
Study Start
August 22, 2022
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share