Recruiting

Cannabinoid Therapy

Sponsor:

Cerebra Medical

Code:

NCT05237037

Conditions

Poor Sleep Quality

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Poor Sleep Quality

Study ID

NCT05237037

Start date

Aug 22, 2022

Status verified date

Feb, 2023

Completion date

Aug, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

34 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in Sleep Quality (Pittsburgh Sleep Quality Index) [ Time Frame: 6 weeks ]
  • Change in Objective Sleep Quality (Odds Ratio Product) [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Ekosi Health Centre

Recruiting

Winnipeg, Manitoba, Canada, R3A 0J5

Contacts

More Information

Sponsor

Cerebra Medical

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Keywords

  • Cannabinoid Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cerebra Medical on 2023-02-08.