RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-24

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05802004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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 \&gt; 14 standard alcoholic drinks per week. Rationale: excessive alcohol consumption may interfere with sleep and cognitive-emotional function. 5. Consumption of \&gt; 400mg of caffeine per day, which is roughly equivalent to 3-4 8oz cups of coffee per day. 6. Drug or alcohol use \&lt; 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 \&gt; 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 (\&lt; 10:00pm, \&gt; 1:00am) or wake times (\&lt; 6:00am, \&gt; 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 (\&lt;5hrs) or long (\&gt;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) \&gt; 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.

Inclusion Criteria

Exclusion 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.

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 \&gt; 14 standard alcoholic drinks per week. Rationale: excessive alcohol consumption may interfere with sleep and cognitive-emotional function.
5. Consumption of \&gt; 400mg of caffeine per day, which is roughly equivalent to 3-4 8oz cups of coffee per day.
6. Drug or alcohol use \&lt; 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 \&gt; 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 (\&lt; 10:00pm, \&gt; 1:00am) or wake times (\&lt; 6:00am, \&gt; 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 (\&lt;5hrs) or long (\&gt;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) \&gt; 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.

Contacts and Locations

Study Contact

Michelle E Stepan, PhD

CONTACT

7247570761

stepanme@upmc.edu

Principal Investigator

Michelle E Stepan, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Michelle Stepan

Michelle E Stepan, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24

Study Completion Date2027-03

Study Record Updates

Study Start Date2024-04-24

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Acoustic Stimulation