A Study on CBN Oil for Sleep

Type

A Questionnaire Study

Study Title

CANNABINOL USAGE & EFFECTIVENESS QUESTIONNAIRE

Study Objectives

The research study questionnaire is aimed to investigate the performance of the hemp-derived minor cannabinoid, cannabinol (CBN). The goal of this study is to evaluate the effectiveness of CBN on various, minor sleep discomforts such as falling asleep or staying asleep.

Study Design

This study will enroll participants that report issues falling or staying asleep. The test results will include 150mg CBN product (Tincture or Softgel) for the participant to take home and use the recommended serving size, 1 hour before bed each night. Data will be collected over 6 days preceding enrollment. Throughout the investigatory period, participants will be sent a daily 5 question survey evaluating the various effects of the CBN hemp supplement on their sleep each night.

Study Observation Team

Participants will be enrolled by a team at Vail Integrative Medical group. Overseen by Dr. Joel Dekanich FNP-C, MSN, DC, MS, DACBSP, CSCS and Dr. Susan Hansen. They will assess participants medication, medical history, and sleep symptoms prior to onboarding. 

Primary Endpoints

The primary endpoint of the study is to analyze the reported preexisting sleep reported issues compared to the percentage of outcome success in the correction of the sleep issue/condition and improvement of participant satisfaction. 

Study Duration

6 days: 1 day to enroll and 6 days for completion and follow-up online survey.

Subject Population

Male and female subjects who claim various, minor discomforts falling asleep or staying asleep.

Inclusion Criteria

• Completion of application form
• Adults over 21
• Approval from physicians after Medical Assessment on medications and allergens.
• Ability to complete a survey sent either via email or text.

Exclusion Criteria

Subjects will be excluded from the Study if they require any of the following criteria:

• Under the age of 21
• Reporting having sleep issues less than 1 day a week
• Possible Allergies or Medical Complications in the product that may be harmful to the participant.
• Pregnant or nursing females
• Inability to complete a daily survey sent either via email or text.

Onboarding and Dispensing

Investigators will need to:

• Review and select appropriate applicants prior to scheduling the onboarding appointment.
• Have the participant review and sign the Patient Consent form including:
  • • The nature and purpose of the research study.
    • The procedures to be followed.
    • Any common or important discomforts and risks.
    • Any benefits you might expect.
    • Participants can opt-out at any time. 
    • No identifiable information will be presented. 
• Select a CBN tincture or softgel as the preferred method of CBN.
  • Ingredients of Tincture: Proprietary Blend: CBN, Organic MCT Oil, Linalool (Lavender), Beta-Caryophyllene, Natural Vanilla, and Orange Flavoring.
  • Ingredients of Softgels: Proprietary Blend: CBN, Organic MCT Oil, Beta-Caryophyllene, Shell (Gelatin, Glycerin, Water).