Assessment of Sleep Quality in Cannabinoid Therapy

Assessment of Sleep Quality in Patients Utilizing Cannabinoid Therapy

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

Study Overview

• Status: Recruiting
• Conditions: Poor Sleep Quality

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.

• Study Type: Observational
• Enrollment (Anticipated): 34

Contacts and Locations

• Study Contact: Name: Shelley Turner, MD; Phone Number: 866-370-8388; Email: sturner@ekosihealth.com

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 0J5
      • Recruiting
      • Ekosi Health Centre
      • Contact: Shelley Turner, MD; Phone Number: 866-370-8388; Email: sturner@ekosihealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Sleep Quality (Pittsburgh Sleep Quality Index)	6 weeks
Change in Objective Sleep Quality (Odds Ratio Product)	6 weeks

Collaborators and Investigators

• Sponsor: Cerebra Medical
• Collaborators: Ekosi Health Centre

Publications and helpful links

General Publications

• Morin 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.
• Johns 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.
• 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.
• Lovibond, S.H., & Lovibond, P.F. Manual for the Depression Anxiety Stress Scales. (2nd Ed.) Sydney: Psychology Foundation. (1995).

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2022
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (ACTUAL): February 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cannabinoid Therapy
• Other Study ID Numbers: Ekosi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No