Assessment of Sleep Quality in Cannabinoid Therapy

Poor Sleep Quality Clinical Trial

Official title:

Assessment of Sleep Quality in Patients Utilizing Cannabinoid Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237037
• Other study ID #: Ekosi
• Status: Recruiting
• Start date: August 22, 2022
• Est. completion date: August 2023

Study information

• Verified date: February 2023
• Source: Cerebra Medical
• Contact: Shelley Turner, MD
• Phone: 866-370-8388
• Email: sturner[@]ekosihealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Poor Sleep Quality

Locations

Country	Name	City	State
Canada	Ekosi Health Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Cerebra Medical	Ekosi Health Centre

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep Quality (Pittsburgh Sleep Quality Index)		6 weeks
Primary	Change in Objective Sleep Quality (Odds Ratio Product)		6 weeks