Clinical trial for Acoustic Stimulation
Official title Acoustic Stimulation, Sleep, and Cognitive-Emotional Processes in Young Adults With Anxiety and Depression Symptoms
ClinicalTrials.gov ID: NCT05802004
What this study is testing
- What it's testing
- In this study, the investigators will recruit young adults (ages 18-25 years) with elevated anxiety/depression symptoms and sleep disturbance. Participants will complete two overnights in a sleep lab.
- Time commitment: about 2 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 25
You may be able to join if
- Age 18-25. Equal numbers of men and women will be included.
- Normal hearing.
- Elevated anxiety or depression symptoms. This will be determined using the PROMIS anxiety and PROMIS depression scales. Participants with T-scores ≥...
- Elevated sleep disturbance. This will be determined using the PROMIS sleep disturbance scale. Participants with T-scores ≥ 55 on the PROMIS sleep...
You likely can't join if
- Presence of a severe chronic or psychiatric condition including psychosis, bipolar disorder, developmental disorders, or substance use disorder.
- Current use of psychotropic medications or medications affecting sleep/wake function, such as antidepressants, antipsychotic medications, steroids...
- Substance abuse. Rationale: Substance abuse may affect sleep and cognitive-emotional function.
- Consumption of \> 14 standard alcoholic drinks per week. Rationale: excessive alcohol consumption may interfere with sleep and cognitive-emotional...
- Consumption of \> 400mg of caffeine per day, which is roughly equivalent to 3-4 8oz cups of coffee per day.
- Drug or alcohol use \< 48 hours before the in-lab overnight sessions. Rationale: Recent drug or alcohol use could affect sleep, cognitive-emotional...
See the full eligibility criteria
- Age 18-25. Equal numbers of men and women will be included.
- Normal hearing.
- Elevated anxiety or depression symptoms. This will be determined using the PROMIS anxiety and PROMIS depression scales. Participants with T-scores ≥ 60 (i.e., ≥ than 1 standard deviation above the mean) on either or...
- Elevated sleep disturbance. This will be determined using the PROMIS sleep disturbance scale. Participants with T-scores ≥ 55 on the PROMIS sleep disturbance scale will be eligible for participation.
- Presence of a severe chronic or psychiatric condition including psychosis, bipolar disorder, developmental disorders, or substance use disorder.
- Current use of psychotropic medications or medications affecting sleep/wake function, such as antidepressants, antipsychotic medications, steroids, and stimulants. Rationale: These medications may affect sleep and...
- Substance abuse. Rationale: Substance abuse may affect sleep and cognitive-emotional function.
- Consumption of \> 14 standard alcoholic drinks per week. Rationale: excessive alcohol consumption may interfere with sleep and cognitive-emotional function.
- Consumption of \> 400mg of caffeine per day, which is roughly equivalent to 3-4 8oz cups of coffee per day.
- Drug or alcohol use \< 48 hours before the in-lab overnight sessions. Rationale: Recent drug or alcohol use could affect sleep, cognitive-emotional processes, and poses a safety risk.
- Severe insomnia or sleep apnea symptoms. Insomnia symptoms will be determined using the Insomnia Severity Index. Participants with severe insomnia (i.e., scores \> 21) will not be eligible. Sleep apnea symptoms will be...
- Extreme bedtimes (\ 1:00am) or wake times (\ 10:00am). Rationale: Participants with extreme bed or wake times may have difficulty falling asleep, waking up, or obtaining a sufficient amount of sleep during the in-lab...
- Short (\ 9hrs) average sleep duration. Rationale: short or long sleepers may have different sleep profiles which could impact the how well it works of the acoustic stimulation intervention.
- Uncorrected vision problems.
- Claustrophobia. Rationale: MRI safety criteria.
- Metal in body. Rationale: MRI safety criteria.
- Body Mass Index (BMI) \> 40. Rationale: MRI safety criteria.
- Pregnancy. Rationale: MRI safety criteria.
- Left handedness. Rationale: Left-handed people may have different lateralization of neural functioning which could affect the fMRI results.
- Formal vocal training and Good/Very Good at singing in tune. Rationale: The purpose of the karaoke task is to induce negative self-referential emotions via out-of-tune singing.
- Does not own a smartphone or tablet. Rationale: Participants may need to download an app (SleepMapper or Alfin) to download their sleep data from the headband device when wearing it at home.
- Inability or unwillingness to complete study procedures.
- Hairstyles that prevent access to the scalp (e.g., weave). Rationale: Polysomnography for the in-lab overnights cannot be applied with hairstyles which prevent access to the scalp to apply electrodes.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 25 years. 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.