Phase
Condition
Auditory Stimulation
Depression
Treatment
No daily acoustic stimulation (SHAM2)
No Acoustic Stimulation (SHAM)
Daily acoustic stimulation (STIM2)
Clinical Study ID
Ages 18-25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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 PROMISanxiety and PROMIS depression scales. Participants with T-scores ≥ 60 (i.e., ≥ than 1 standard deviation above the mean) on either or both scales will be eligible forparticipation.
Elevated sleep disturbance. This will be determined using the PROMIS sleepdisturbance scale. Participants with T-scores ≥ 55 on the PROMIS sleep disturbancescale will be eligible for participation.
Exclusion
Exclusion Criteria:
Presence of a severe chronic or psychiatric condition including psychosis, bipolardisorder, developmental disorders, or substance use disorder.
Current use of psychotropic medications or medications affecting sleep/wakefunction, such as antidepressants, antipsychotic medications, steroids, andstimulants. Rationale: These medications may affect sleep and cognitive-emotionalfunction.
Substance abuse. Rationale: Substance abuse may affect sleep and cognitive-emotionalfunction.
Consumption of > 14 standard alcoholic drinks per week. Rationale: excessivealcohol 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-emotionalprocesses, and poses a safety risk.
Severe insomnia or sleep apnea symptoms. Insomnia symptoms will be determined usingthe Insomnia Severity Index. Participants with severe insomnia (i.e., scores > 21) will not be eligible. Sleep apnea symptoms will be determined using theSTOP-Bang questionnaire. Participants with scores ≥ 3 will not be eligible.Rationale: Sleep disturbances which result in low sleep efficiency and frequentawakenings during the night may reduce the effectiveness of acoustic stimulationwhich targets the deepest stage of sleep (i.e., slow-wave sleep).
Extreme bedtimes (< 10:00pm, > 1:00am) or wake times (< 6:00am, > 10:00am). Rationale: Participants with extreme bed or wake times may havedifficulty falling asleep, waking up, or obtaining a sufficient amount of sleepduring the in-lab overnight sessions.
Short (<5hrs) or long (>9hrs) average sleep duration. Rationale: shortor long sleepers may have different sleep profiles which could impact theeffectiveness 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 ofneural functioning which could affect the fMRI results.
Formal vocal training and Good/Very Good at singing in tune. Rationale: The purposeof the karaoke task is to induce negative self-referential emotions via out-of-tunesinging.
Does not own a smartphone or tablet. Rationale: Participants may need to download anapp (SleepMapper or Alfin) to download their sleep data from the headband devicewhen 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 whichprevent access to the scalp to apply electrodes.
Study Design
Study Description
Connect with a study center
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
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