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Not yet recruitingNCT06881875Updated Mar 18, 2025

AI-Guided Stress Management Breathing Practices Via a Wearable Device

An interventional study of AI-guided breathing practices and Progressive muscle relaxation in Stress Reduction, sponsored by Peking University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Peking University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

This study explores the effectiveness of AI-guided breathing practices for stress management in adults. In this randomized controlled trial, 120 participants will be recruited and assigned to an intervention group (n=90) or a control group (n=30). The study includes four brief breathing practices, guided by a wristband. The intervention group will interact with an AI chatbot to receive a personalized daily breathing plan for 28 days, adjusted weekly based on feedback. Meanwhile, the control group will practice progressive muscle relaxation daily. It is hypothesized that, the intervention group will have significantly improvements in stress management and emotion regulation skills compare to the control group. These group differences are expected to persist at 1-month, 3-month and 6-month follow-up assessment.

02

Conditions studied

  • Stress Reduction

Keywords

  • stress reduction
  • breathing practices
  • wearable device
  • AI guided intervention
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 120 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Currently enrolled college students.
  2. Aged between 18 and 30 years old.

Exclusion criteria

Exclusion Criteria:

  1. Current or past history of psychotic disorders.
  2. Using contraceptives, cortisol, beta-blockers, antidepressants, or other psychiatric medications, as well as medications for chronic diseases during the intervention and follow-up periods.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Behavioral: AI-guided breathing practices

  • Active comparator
    Control group

    Behavioral: Progressive muscle relaxation

Interventions

  • BehavioralAI-guided breathing practices

    Participant will obtain a wristband with a built-in breathing practices program when assigned to the intervention group. Four kinds of breathing practices are included, which are bee breathing, diaphragmatic breathing, box breathing and 4-7-8 breathing. A specially prompted AI chat bot interviews the participant and designs a personalized daily breathing practice plan according to participant's preference and daily stress. Participant follows the plan in the following 28-day intervention period. Plan is adjusted weekly based on participant's feedback.

  • BehavioralProgressive muscle relaxation

    Participant practices progressive muscle relaxation for 5 minutes daily.

06

What researchers measure

Primary outcomes

  1. Perceived stress

    The investigators will explore the effectiveness of the AI-guided breathing practices on stress management using a self-developed stress questionnaire. The questionnaire consists of 15 items, each rated on a 5-point scale, with higher scores indicating greater perceived stress.

    Time frame: baseline, daily for 28 days, post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

  2. Emotion

    The investigators will explore the effectiveness of the AI-guided breathing practices on emotion using the positive and negative affect schedule(PANAS). The questionnaire consists of 20 items, each rated on a 5-point scale, with higher scores on the negative affect subscale indicating greater negative emotion, and higher scores on the positive affect subscale indicating greater positive emotion.

    Time frame: baseline, daily for 28 days, post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

Secondary outcomes

  1. Sleep quality

    The investigators will explore the effectiveness of the AI-guided breathing practices on enhancing sleep quality using the insomnia severity index(ISI). The questionnaire consists of 7 items, each rated on a 5-point scale, with higher scores indicating worse sleep quality.

    Time frame: baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

  2. Alexithymia

    The investigators will explore the effectiveness of the AI-guided breathing practices on reducing alexithymia using a self-developed alexithymia questionnaire. The questionnaire consists of 23 items, each rated on a 5-point scale, with higher scores indicating greater alexithymia.

    Time frame: baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

  3. Irritation

    The investigators will explore the effectiveness of the AI-guided breathing practices on reducing irritation using a self-developed irritation questionnaire. The questionnaire consists of 18 items, each rated on a 5-point scale, with higher scores indicating greater irritation.

    Time frame: baseline, mid-treatment(2 weeks), post-treatment(5 weeks), 10 weeks, 18 weeks, 30 weeks

07

Study locations

1 site
  • Peking University
    Beijing, Beijing 100871, China
    • Yinyin Zang, PhD · Contact · yinyin.zang@pku.edu.cn · +86-010-62756953
    • Yinyin Zang, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06881875
Lead sponsor
Peking University
Responsible party
Yinyin Zang, PhD (Principal Investigator, Peking University) — Principal investigator
First posted
Mar 18, 2025
Start date
Mar 15, 2025 (estimated)
Primary completion
Sep 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Mar 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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