Cannabis Association With Sleep Study (CaSS)

Oregon Health & Science University (OHSU)

Status: Not yet enrolling

Conditions: Sleep

Treatments: Other: Manipulation of Sleep Duration

Study type: Interventional

Funder types: Other

Identifiers

NCT06982950

IRB28366

Details and patient eligibility

About

The purpose of this study is to learn more about cannabis use, sleep, and stress, and whether there is any relationship between the three.

Full description

After passing a physical assessment and psychological screen, 60 participants will be enrolled. Ahead of the 21-day protocol participants will report to our laboratory sleep facilities and will be set-up to perform a full polysomnography test (monitored overnight sleep with equipment including superficial electrodes, heart rate [HR] monitor, breathing monitors). This initial night of sleep with study equipment is provided in order to reduce sleep differences based on sleeping in a new environment and the burden of wearing equipment while sleeping. Before and after this 8h sleep period participants will be introduced to all surveys and behavioral testing that will be used as part of the experimental nights. Participants who complete the familiarization night will be randomized to two different possible experimental protocols that differ in the length of the sleep period. In order to fully characterize cannabis use behaviors (frequency, amount, mode of use) on sleep in an individual's typical environment (i.e. in the places and during the activities of normal living), we will implement 21 days of activity monitoring via multiple daily surveys (which collectively is a research strategy known as Ecological Monitoring Assessment [i.e., EMA]) along with concurrent actigraphy, that is, the monitoring of movement via the use of a wrist-worn watch-like device. Approximately one-week into this observational period, participants will complete the 2 x 4-night experimental nights (consecutive nights) with a washout (return to habitual sleep patterns) of at least 6 days.

Participants are able to spend the day outside of the laboratory during the experimental night period (i.e. they will come into the lab each night to sleep, and have their sleep monitored, but able to do normal activities during the days). Following in laboratory assessments, participants will complete any remaining at home assessments needed for 21 days of EMA/actigraphy.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• fluent in English
• 18.5<BMI<40 kg/m2
• no shift work in the last 12 months
• no travel across time zones in the last 2 months.

Exclusion criteria

• Chronic disease-Medical history/prior diagnosis of the following:
• cardiometabolic disease (e.g., myocardial infarction, angina, diabetes)
• essential hypertension
• hepatic impairment
• severe obstructive sleep apnea
• restless legs syndrome
• parasomnia
• neurological disease (e.g., early onset dementia)
• unstable psychiatric disorders (e.g., bipolar disorder, schizophrenia, major depression with suicidality).
• Drug/Alcohol use criteria:
• Illicit drugs apart from cannabis or related products are prohibitive.
• Volunteers may consume caffeine, however, >3 cups of coffee (or otherwise equivalent of >300mg/day) is prohibitive.
• Participants who consume >14 alcoholic drinks/week and/or have a diagnosis (or history) of alcohol use disorder will be excluded (a toxicological urine screen will be conducted to verify reported non-use during the initial screening and on the day of admission to the in-laboratory portion of the study).
• Use of prescription or over-the-counter medications or supplements that affect sleep are also exclusionary.
• Contraceptives are required for women and will continue to be taken throughout the experiment.
• Prior Shift Work:
• Volunteers must have no history of working irregular day and night hours, regular night work, or rotating shift work for the 3 months prior to the study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Sleep Restriction

Experimental group

Description:

After a baseline assessment of sleep, participants in this arm will undergo 2 nights of restricted sleep (4 hour time in bed).

Treatment:

Other: Manipulation of Sleep Duration

Sleep Extension

Experimental group

Description:

After a baseline assessment of sleep, participants in this arm will undergo 3 nights of an extended sleep opportunity (10 hour time in bed).

Treatment:

Other: Manipulation of Sleep Duration