SleepCaSSNCT06982950
Cannabis Association With Sleep Study
A study testing Manipulation of Sleep Duration in people with Sleep, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to learn more about cannabis use, sleep, and stress, and whether there is any relationship between the three. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Manipulation of Sleep Duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU
Portland, Oregon, 97239
Nicole Bowles, PhD, 5034942541, circadian@ohsu.edu
About this study
Official title: Longitudinal Reciprocal Relationships Between Cannabis Use, Sleep, and the HPA-axis (CaSS)
The purpose of this study is to learn more about cannabis use, sleep, and stress, and whether there is any relationship between the three.
Read the detailed 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.
- Conditions
- Sleep
- Being tested
- Manipulation of Sleep Duration
- Keywords
- Sleep, slow wave, Polysomnography, Marijuana Abuse, Cannabinoids, Ecological Momentary Assessment, Sleep Duration
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulation of Sleep DurationOther
After a baseline assessment of sleep, participants will undergo either 2 nights of restricted sleep (4 hour time in bed) followed by a recovery sleep, OR 3 nights of an extended sleep opportunity (10 hour time in bed)
| Study group | Role | What they receive |
|---|---|---|
| Sleep Restriction | Experimental | After a baseline assessment of sleep, participants in this arm will undergo 2 nights of restricted sleep (4 hour time in bed). Receives: Other: Manipulation of Sleep Duration |
| Sleep Extension | Experimental | After a baseline assessment of sleep, participants in this arm will undergo 3 nights of an extended sleep opportunity (10 hour time in bed). Receives: Other: Manipulation of Sleep Duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Cannabis Use Frequency
The number of smoking/vaping sessions per day.
Measured: Assessed in surveys performed 4 times per day, and across the entire 21-day study
Wake After Sleep Onset (WASO)
Wake after sleep onset (measured in minutes) will be assessed each night from actigraphy; larger value indicates greater disruptions to sleep.
Measured: 21 days
Cortisol Awakening Response
Salivary cortisol levels assessed as the difference between waking and peak levels assessed ~30-45 minutes after awakening.
Measured: 8 nights
Secondary outcomes (18)
Wake After Sleep Onset (Polysomnography)
Wake after sleep onset (measured in minutes) will be assessed each night of the in laboratory study using polysomnography [PSG]); larger value indicates greater disruptions to sleep.
Measured: 8 nights
Sleep Latency
Measured in minutes and assessed each night of the in laboratory study using polysomnography; assessed at time from in bed and lights off to any stage of sleep including Non rapid eye movement (NREM) 1.
Measured: 8 nights
Total Sleep Time
Measured (in minutes)from actigraphy (21 days of data) and in laboratory study using polysomnography (8 nights of data).
Measured: up to 21 days
Sleep Macroarchitecture
Non rapid eye movement (NREM) 1-3 and Rapid eye movement (REM), time and %, assessed each night of the in laboratory study using polysomnography.
Measured: 8 nights
Sleep Microarchitecture
Delta power, theta power, and alpha power during quiet wakefulness and sleep assessed during the in laboratory study using polysomnography.
Measured: 8 nights
Median Reaction Time
Assessed from a 10 minute psychomotor vigilance test approximately hourly during the in laboratory component of the study; larger value indicates reduced vigilance.
Measured: 8 days
Time to NREM1 Sleep (modified Maintenance of Wakefulness)
Assessment of sleep pressure using a modified Maintenance of Wakefulness test provided approximately hourly during the in laboratory component of the study.
Measured: 8 days
Subjective Sleepiness
Assessed 4-5 times/day as part of the Ecological Monitoring Assessment (EMA) and approximately hourly during the in laboratory component of the study using the Karolinska Sleepiness Scale (KSS). The KSS uses a 9-point scale with 1 = extremely alert and 9 = extremely sleepy - fighting sleep.
Measured: 21 days
Pre-Ejection Period
Using continuous electrocardiogram (EKG) during the in laboratory portion of the study we will calculate the interval between the Q wave on the EKG signal and the B point on the dZ/dt signal.
Measured: 8 days
Sleep High Frequency Heart Rate Variability (HRV)
Assessed from continuous EKG during the in laboratory portion of the study, high frequency (HF; 0.15-0.4 Hz) HRV will be calculated by passing R-R intervals through a fast Fourier power spectral analysis on all 2-minute periods of nocturnal EKG of stable PSG identified sleep.
Measured: 8 nights
Mood
Daily assessments of mood will be collected during the EMA using abbreviated versions of Profile of Mood States (POMS) with each mood description rated on a 5-point scale between not at all (0) to extremely (4).
Measured: 21 days
Cannabis Use Composite Score
Composite score based on daily frequency of use, amount of use, time of use, and method of use.
Measured: 21 days
Positive Affect
Daily assessments of positive affect will be collected during the EMA using The Positive and Negative Affect Schedule (PANAS) scales with values ranging from 10-50 (high score representing higher levels of positive affect).
Measured: 21 days
Negative Affect
Daily assessments of negative affect will be collected during the EMA using the PANAS with values ranging from 10-50 (lower scores representing lower levels of negative affect).
Measured: 21 days
Sleep Low Frequency HRV
Assessed from continuous EKG during the in laboratory portion of the study, low frequency (LF; 0.04-0.15 Hz) HRV will be calculated by passing R-R intervals through a fast Fourier power spectral analysis on all 2-minute periods of nocturnal EKG of stable PSG identified sleep.
Measured: 8 nights
Sleep Normalized HF Power
Normalized HF power is calculated by dividing integrated HF spectra by the total power (LF+HF) and multiplying by 100.
Measured: 8 nights
Sleep standard deviation of the R-R interval of normal sinus beats (SDNN)
Time domain HRV will be expressed using the standard deviation of the R-R interval of normal sinus beats (SDNN) during stable 2-minute segments of sleep.
Measured: 8 nights
Area under the curve of the CAR
Total amount of cortisol secreted after awakening assessed using the trapezoidal rule to assess area under the curve from waking to 60 minutes post waking saliva cortisol levels.
Measured: 8 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Mar 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After a baseline assessment of sleep, participants will undergo either 2 nights of restricted sleep (4h time in bed \[TIB\]) followed by a recovery sleep, OR 3 nights of an extended sleep opportunity (10h TIB)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Bowles, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982950
- Sponsor's protocol ID
- IRB28366
- Acronym
- CaSS
- Status last verified
- Oct 2026
- First submitted
- 3 May 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Reciprocal Relationships Between Cannabis Use, Sleep, and the HPA-axis (CaSS)
- ClinicalTrials.gov ID
- NCT06982950
- Acronym / sponsor ID
- CaSS / IRB28366
- Conditions
- Sleep
- Keywords
- Sleep, slow wave, Polysomnography, Marijuana Abuse, Cannabinoids, Ecological Momentary Assessment, Sleep Duration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about cannabis use, sleep, and stress, and whether there is any relationship between the three.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After a baseline assessment of sleep, participants will undergo either 2 nights of restricted sleep (4h time in bed [TIB]) followed by a recovery sleep, OR 3 nights of an extended sleep opportunity (10h TIB)
| Arm | Type | Receives |
|---|---|---|
| Sleep Restriction | Experimental | Other: Manipulation of Sleep DurationAfter a baseline assessment of sleep, participants in this arm will undergo 2 nights of restricted sleep (4 hour time in bed). |
| Sleep Extension | Experimental | Other: Manipulation of Sleep DurationAfter a baseline assessment of sleep, participants in this arm will undergo 3 nights of an extended sleep opportunity (10 hour time in bed). |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manipulation of Sleep DurationAfter a baseline assessment of sleep, participants will undergo either 2 nights of restricted sleep (4 hour time in bed) followed by a recovery sleep, OR 3 nights of an extended sleep opportunity (10 hour time in bed) | Other | Sleep Extension, Sleep Restriction |
Primary outcome
Daily Cannabis Use Frequency
Time frame: Assessed in surveys performed 4 times per day, and across the entire 21-day study
The number of smoking/vaping sessions per day.
Wake After Sleep Onset (WASO)
Time frame: 21 days
Wake after sleep onset (measured in minutes) will be assessed each night from actigraphy; larger value indicates greater disruptions to sleep.
Cortisol Awakening Response
Time frame: 8 nights
Salivary cortisol levels assessed as the difference between waking and peak levels assessed ~30-45 minutes after awakening.
18 secondary outcomes
Wake After Sleep Onset (Polysomnography)
Time frame: 8 nights
Sleep Latency
Time frame: 8 nights
Total Sleep Time
Time frame: up to 21 days
Sleep Macroarchitecture
Time frame: 8 nights
Sleep Microarchitecture
Time frame: 8 nights
Median Reaction Time
Time frame: 8 days
Time to NREM1 Sleep (modified Maintenance of Wakefulness)
Time frame: 8 days
Subjective Sleepiness
Time frame: 21 days
Pre-Ejection Period
Time frame: 8 days
Sleep High Frequency Heart Rate Variability (HRV)
Time frame: 8 nights
Mood
Time frame: 21 days
Cannabis Use Composite Score
Time frame: 21 days
Positive Affect
Time frame: 21 days
Negative Affect
Time frame: 21 days
Sleep Low Frequency HRV
Time frame: 8 nights
Sleep Normalized HF Power
Time frame: 8 nights
Sleep standard deviation of the R-R interval of normal sinus beats (SDNN)
Time frame: 8 nights
Area under the curve of the CAR
Time frame: 8 nights
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation of Sleep Duration in people with Sleep, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Bowles, PhD (5034942541, circadian@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Cannabis Use Frequency (time frame: Assessed in surveys performed 4 times per day, and across the entire 21-day study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.