RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks, 1 week
  • Procedures mentioned: MRI scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "When interested participants are identified through recruitment methods, they will be directed to complete an online screening survey."
  • "Participants will be told to maintain a consistent sleep schedule (+/- 1hr around wake and bedtimes) for one week before each overnight."
  • "They will be screened for drug/alcohol use through a subjective questionnaire."
  • "Post-sleep, participants will again complete a set of tasks and questionnaires assessing mood, sleepiness, cognition, and emotional processing."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether soft tones played through a headband during deep sleep affect thinking, emotions, and anxiety or depression symptoms. It is for adults ages 18–25 with anxiety or depression symptoms and sleep problems. Participants spend two nights in a sleep lab, wear the headband at home for about two weeks, and complete tests.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–25. The study will include equal numbers of men and women.
  • Normal hearing.
  • Anxiety or depression symptoms that meet the study's survey cutoff (PROMIS score of 60 or higher).
  • Sleep problems that meet the study's survey cutoff (PROMIS score of 55 or higher).

Who can't join

  • A serious long-term illness or mental health condition, including psychosis, bipolar disorder, a developmental disorder, or a substance use disorder; or substance abuse.
  • Taking medicines that affect mental health, sleep, or waking, such as antidepressants, antipsychotics, steroids, or stimulants.
  • More than 14 standard alcoholic drinks a week; more than 400 mg of caffeine a day; or drug or alcohol use within 48 hours before a sleep-lab night.
  • Severe trouble sleeping (Insomnia Severity Index score above 21), or signs of sleep apnea—breathing pauses during sleep (STOP-Bang score of 3 or higher).
  • Bedtime before 10 p.m. or after 1 a.m.; waking before 6 a.m. or after 10 a.m.; or sleeping less than 5 or more than 9 hours on average.
  • Vision problems that are not corrected; fear of enclosed spaces; metal in the body; pregnancy; or body mass index (BMI, a weight-to-height measure) above 40.
  • Being left-handed; or having formal voice training and being good or very good at singing in tune.
  • Not owning a smartphone or tablet; being unable or unwilling to complete study steps; or having a hairstyle that blocks access to the scalp for sleep sensors.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age 18-25. Equal numbers of men and women will be included. 2. Normal hearing. 3. 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. 4. 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. Exclusion Criteria: 1. Presence of a severe chronic or psychiatric condition including psychosis, bipolar disorder, developmental disorders, or substance use disorder. 2. 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. 3. Substance abuse. Rationale: Substance abuse may affect sleep and cognitive-emotional function. 4. Consumption of \> 14 standard alcoholic drinks per week. Rationale: excessive alcohol consumption may interfere with sleep and cognitive-emotional function. 5. Consumption of \> 400mg of caffeine per day, which is roughly equivalent to 3-4 8oz cups of coffee per day. 6. 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. 7. 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). 8. 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. 9. 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. 10. Uncorrected vision problems. 11. Claustrophobia. Rationale: MRI safety criteria. 12. Metal in body. Rationale: MRI safety criteria. 13. Body Mass Index (BMI) \> 40. Rationale: MRI safety criteria. 14. Pregnancy. Rationale: MRI safety criteria. 15. Left handedness. Rationale: Left-handed people may have different lateralization of neural functioning which could affect the fMRI results. 16. 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. 17. 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. 18. Inability or unwillingness to complete study procedures. 19. 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.

Study sites (1)

PA