Clinical trial NCT05237037: Assessment of Sleep Quality in Cannabinoid Therapy
Official title: Assessment of Sleep Quality in Patients Utilizing Cannabinoid Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Poor Sleep Quality
Keywords: Cannabinoid Therapy
Lead sponsor: Cerebra Medical
Sponsor class: INDUSTRY
Collaborators: name: Ekosi Health Centre
First posted: 2022-02-11
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Sleep Quality (Pittsburgh Sleep Quality Index)
timeFrame: 6 weeks
measure: Change in Objective Sleep Quality (Odds Ratio Product)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Ekosi Health Centre
state: Manitoba
Study officials:
References:
citation: 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.
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.
citation: 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.
citation: Lovibond, S.H., & Lovibond, P.F. Manual for the Depression Anxiety Stress Scales. (2nd Ed.) Sydney: Psychology Foundation. (1995).