New treatment option for Sleep
Official title Circadian Rhythms and Homeostatic Sleep Drive and Their Effect on Reward and Cognitive Control Systems in Adolescents
ClinicalTrials.gov ID: NCT05336084
What this study is testing
- What it's testing
- Adolescence is a time of heightened reward sensitivity and greater impulsivity. On top of this, many teenagers experience chronic sleep deprivation and misalignment of their circadian rhythms due to biological shifts in their sleep/wake patterns paired with early school start times, which may increase the risk for substance use (SU).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 18. Healthy volunteers may be eligible.
You may be able to join if
- Age 13-18 years
- Currently enrolled in a traditional high-school (not cyber- or home-schooled) [school closures during the COVID-19 pandemic are an exception to this]
- Physically and psychiatrically healthy
- Provision of written informed consent and assent
You likely can't join if
- outside age range above
- have a history of alcohol, cannabis, or illicit drug use greater than weekly use in the past year
- have serious medical or neurological disorders, including history of seizures
- have serious psychiatric disorders (e.g. bipolar disorder and schizophrenia)
- taking antidepressants (SSRIs/SSNIs are OK) or medications known to impact sleep/wake function - some medications may be okay if willing and able to...
- have sleep disorders other than insomnia or Delayed Sleep Phase Disorder
See the full eligibility criteria
- Age 13-18 years
- Currently enrolled in a traditional high-school (not cyber- or home-schooled) [school closures during the COVID-19 pandemic are an exception to this]
- Physically and psychiatrically healthy
- Provision of written informed consent and assent
- outside age range above
- have a history of alcohol, cannabis, or illicit drug use greater than weekly use in the past year
- have serious medical or neurological disorders, including history of seizures
- have serious psychiatric disorders (e.g. bipolar disorder and schizophrenia)
- taking antidepressants (SSRIs/SSNIs are OK) or medications known to impact sleep/wake function - some medications may be okay if willing and able to discontinue prior to and/or for laboratory procedures
- have sleep disorders other than insomnia or Delayed Sleep Phase Disorder
- have MRI contraindications (i.e., metal in the body; claustrophobia)
- first degree relative with bipolar disorder
- frequent headaches or migraines
- inability to swallow pills/capsules.
- pregnancy
- participants with observed Obstructive Sleep Apnea via Apnealink, as indicated by an Apnea Hypopnea Index (AHI) of greater than 5
- Less than 80 lbs. or a BMI of greater than 35
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.