Assessment of Sleep Quality in Cannabinoid Therapy

Recruiting

• Conditions: Poor Sleep Quality

• Registration Number: NCT05237037
• Lead Sponsor: Cerebra Medical

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.

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Study Start: 2022-08-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Sleep Quality (Pittsburgh Sleep Quality Index)	6 weeks
Change in Objective Sleep Quality (Odds Ratio Product)	6 weeks

Trial Locations

Locations (1)

Ekosi Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada