Enhancing sleep quality in young adults with anxiety and depression using acoustic stimulation

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

This study is testing if using a special headband that plays sounds while you sleep can help young adults with anxiety and depression sleep better and feel less anxious or depressed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 25 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT05802004 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the effects of acoustic stimulation on sleep and cognitive-emotional processes in young adults aged 18-25 who exhibit symptoms of anxiety and depression. Participants will undergo two overnight sessions in a sleep lab, where one session will involve the use of a headband device that delivers auditory tones to enhance slow-wave sleep, while the other will not. Following these sessions, participants will use the headband at home for two weeks, with half receiving the tones nightly and the other half not. Cognitive and emotional assessments will be conducted to evaluate the impact of the intervention on anxiety and depression symptoms.

Who should consider this trial

Good fit: Ideal candidates are young adults aged 18-25 with elevated anxiety and depression symptoms and sleep disturbances.

Not a fit: Patients with severe chronic or psychiatric conditions, or those currently using psychotropic medications, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve sleep quality and reduce anxiety and depression symptoms in young adults.

How similar studies have performed: Other studies have shown promise in using acoustic stimulation for sleep enhancement, suggesting potential for success in this novel application.

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.

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Michelle E Stepan, PhD — University of Pittsburgh
• Study coordinator: Michelle E Stepan, PhD

Conditions Acoustic Stimulation; Acoustic stimulation; Slow-wave activity; Anxiety; Depression; Cognitive control; Emotion; Daily acoustic stimulation