What this study is
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.
What's being tested
- Acoustic Stimulation (STIM)
Intervention · DEVICE
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).
- No Acoustic Stimulation (SHAM)
Intervention · DEVICE
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.
- Daily acoustic stimulation (STIM2)
Intervention · DEVICE
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).
- No daily acoustic stimulation (SHAM2)
Intervention · DEVICE
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.
Study details
- Official title
- 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
- Conditions
- Acoustic Stimulation
- Enrolling
- 40 people
- Starts
- 2024-04-24
- Est. completion
- 2027-03
- Design
- Single-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 25 YearsSex ALLHealthy volunteers Not acceptedYou may qualify 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 ≥ 60 (i.e., ≥ than 1 standard deviation above the mean) on either or both scales will be eligible for participation.
- 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.
You 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, and stimulants. Rationale: These medications may affect sleep and cognitive-emotional function.
- 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 determined using the STOP-Bang questionnaire. Participants with scores ≥ 3 will not be eligible. Rationale: Sleep disturbances which result in low sleep efficiency and frequent awakenings during the night may reduce the effectiveness of acoustic stimulation which 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 have difficulty falling asleep, waking up, or obtaining a sufficient amount of sleep during the in-lab overnight sessions.
- Short (<5hrs) or long (>9hrs) average sleep duration. Rationale: short or long sleepers may have different sleep profiles which could impact the effectiveness 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Michelle E Stepan, PhD · Contact7247570761stepanme@upmc.edu
Recruiting
Study team
Sponsor
Michelle Stepan
Study ID STUDY22040183
Principal investigator
Michelle E Stepan, PhD
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.