RecruitingNot ApplicableNCT05802004

Acoustic Stimulation, Sleep, and Cognitive-Emotional Processes in Young Adults With Anxiety and Depression Symptoms

The Effect of Acoustic Enhancement of Slow-Wave Activity on Cognitive Control and Emotional Reactivity in Young Adults With Anxiety and Depression Symptoms


Sponsor

Michelle Stepan

Enrollment

40 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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. During one of the overnights, slow-wave activity will be enhanced by delivering sub-arousal auditory tones during slow-wave sleep using a headband device (Philips SmartSleep or Dreem 2). During the other overnight, tones will not be administered. Cognitive and emotional processes will be evaluated using behavioral task performance, self-report, and functional magnetic resonance imaging (fMRI). After the second overnight, participants will take the headband device home and wear it every night for approximately 2 weeks. For half of the participants, the headband will play tones every night and, for the other half, the headband will not play tones. Participants will then return for a final testing visit in which cognitive and emotional processes and anxiety/depression symptoms will be assessed using behavioral task performance and self-report.


Eligibility

Min Age: 18 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether gentle sound stimulation delivered during sleep (acoustic neurofeedback) can improve sleep quality and reduce anxiety and depression symptoms in young adults who struggle with both sleep problems and emotional difficulties. **You may be eligible if:** - You are between 18 and 25 years old - You have normal hearing - You have elevated anxiety or depression symptoms (above average on a standard scale) - You also have elevated sleep disturbance (above a set threshold on a sleep scale) **You may NOT be eligible if:** - You have a serious psychiatric condition such as psychosis, bipolar disorder, or a developmental disorder - You currently take medications that affect sleep or mood (antidepressants, antipsychotics, stimulants, steroids) - You have a substance use disorder - You drink more than 14 alcoholic drinks per week - You consume more than 400mg of caffeine per day (about 3–4 cups of coffee) - You have used drugs or alcohol within 48 hours before an in-lab overnight session Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAcoustic Stimulation (STIM)

During the in-lab overnight, a headband device will be used to administer acoustic stimulation. Tones will be played during slow-wave sleep to enhance underlying slow-wave activity (0.5 - 4 Hz delta spectral power).

DEVICENo Acoustic Stimulation (SHAM)

During the in-lab overnight, the participant will wear a headband device, but the device will not administer acoustic stimulation. The device will be on and will still monitor sleep, but will not play tones.

DEVICEDaily acoustic stimulation (STIM2)

During the \~2 weeks at home, a headband device will be used to administer acoustic stimulation. Tones will be played during slow-wave sleep to enhance underlying slow-wave activity (0.5 - 4 Hz delta spectral power).

DEVICENo daily acoustic stimulation (SHAM2)

During the \~2 weeks at home, the participant will wear a headband device, but the device will not administer acoustic stimulation. The device will be on and will still monitor sleep, but will not play tones.


Locations(1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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NCT05802004


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