ClinicalTrials.gg
RecruitingNCT07437833Updated Nov 2, 2026

Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder

An interventional study of Moderate-Intensity Aerobic Exercise on Cycloergometer and Cyclic Sighing in ADHD - Attention Deficit Disorder With Hyperactivity and Bipolar Affective Disorder; Remission in, sponsored by Poznan University of Physical Education. Recruiting at 1 site in Poland. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Nov 2, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

This study aims to explore how six short, 15-minute self-regulation techniques affect the body and brain in a female adult with ADHD and stabilized bipolar disorder. The techniques being tested include:

  • Aerobic exercise
  • Controlled breathing (cyclic sighing)
  • Aromatherapy with lavender essential oil
  • Listening to specific music (Solfeggio 528 Hz)
  • Virtual reality relaxation with forest imagery
  • Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison.

The participant will attend one 15-minute session per week for each technique. Before and after each session, the researchers will measure:

  • Heart rate and heart rate variability
  • Stress levels using Subjective Units of Distress Scale
  • Mood using a questionnaire
  • Blood pressure
  • Brain activity using EEG
  • Memory performance with a simple test (N-back)
  • Pain sensitivity The goal is to understand how these short, non-invasive techniques influence both physiological and psychological responses. Sessions are safe, short, and designed to involve minimal risk. The findings may help guide future research on relaxation and exercise strategies for people with ADHD and bipolar disorder.
02

Conditions studied

  • ADHD - Attention Deficit Disorder With Hyperactivity
  • Bipolar Affective Disorder; Remission in
03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 1 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Poznan University of Physical Education is the lead sponsor of 90 studies on the registry; 27 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of ADHD and bipolar disorder (type I or II) in stable remission.
  • No active depressive, manic, or psychotic episodes for at least 2 years.
  • No use of psychotropic medications, including mood stabilizers, antidepressants, antipsychotics, or ADHD medications, for at least 2 years.
  • No chronic somatic diseases (including neurological, cardiovascular, or metabolic disorders).
  • Regular sleep-wake rhythm during the week preceding the study.
  • Non-smoker.
  • No night-shift work in the week preceding the study.

Exclusion criteria

Exclusion Criteria:

  • Acute medical conditions that could affect study procedures.
  • Use of medications in the past 3 months that influence cardiovascular or neurological parameters.
  • Consumption of alcohol or psychoactive substances on the day before or day of the study.
  • Intense physical activity on the day before or day of the study.
  • to moderate-intensity exercise on a cycle ergometer (e.g., recent injuries, chronic musculoskeletal conditions).
  • Contraindications to EEG measurement (e.g., scalp skin conditions preventing proper electrode placement, to conductive gels or pastes).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (estimated)

Study arms

  • Other
    All Interventions and Control Session - Single Participant

    One participant receives six 15-minute self-regulation interventions (moderate-intensity aerobic exercise on cycloergometer, cyclic sighing, lavender aromatherapy, Solfeggio 528 Hz music therapy, virtual reality forest relaxation, Emotional Freedom Technique tapping) and one control session (quiet sitting). Each session occurs weekly, and measurements are taken before and after each session.

    Behavioral: Moderate-Intensity Aerobic Exercise on Cycloergometer · Behavioral: Cyclic Sighing · Behavioral: Aromatherapy · Behavioral: Music Therapy · Behavioral: Virtual Reality Nature Immersion · Behavioral: Emotional Freedom Technique Tapping · Behavioral: Resting State (Control Session)

Interventions

  • BehavioralModerate-Intensity Aerobic Exercise on Cycloergometer

    The participant performs a 15-minute session of moderate-intensity cycling on a stationary ergometer. Moderate intensity is defined as 64-76% of maximum heart rate according to ACSM guidelines. The exercise load is set to 2 watts per kilogram of body weight. Heart rate is monitored using a Polar chest strap.

    Also known as: Physical Exercise

  • BehavioralCyclic Sighing

    The participant performs cyclic sighing for 15 minutes while sitting in a chair. They inhale slowly, and once the lungs are expanded, perform a second inhale to maximally fill the lungs, even if the second inhale is shorter or smaller in volume than the first. They then slowly and fully exhale all their breath. The participant performs all inhales and exhales through the nose.

    Also known as: Breathing Exercises

  • BehavioralAromatherapy

    The participant undergoes a 15-minute aromatherapy session while sitting comfortably in a chair in a closed room (2 m × 4 m). Lavender essential oil is diffused into the air using an aroma diffuser placed approximately 1 meter from the participant. The participant breathes normally and does not perform controlled breathing.

    Also known as: Lavender Essential Oil Inhalation

  • BehavioralMusic Therapy

    The participant listens to 528 Hz solfeggio frequency music for 15 minutes while seated comfortably in a quiet, closed room. Music is delivered through headphones or a speaker at a comfortable volume.

    Also known as: Solfeggio 528 Hz Frequency Music Exposure

  • BehavioralVirtual Reality Nature Immersion

    The participant wears a VR headset and views a 15-minute immersive forest and nature environment while seated comfortably in a quiet, closed room. The VR experience includes visual and auditory elements of a natural forest scene.

    Also known as: VR Relaxation

  • BehavioralEmotional Freedom Technique Tapping

    The participant performs a 15-minute Emotional Freedom Technique (EFT) tapping session while seated comfortably in a quiet, closed room. The participant taps on standardized acupressure points in the following order: karate chop (side of hand), inner eyebrow, side of eye, under eye, under nose, chin, collarbone, under arm, and top of head. Each point is tapped 10-15 times with steady, moderate pressure.

    Also known as: Tapping on Acupuncture Points

  • BehavioralResting State (Control Session)

    The participant sits quietly in a chair with eyes open for 15 minutes in a calm, closed room. No active intervention, tapping, breathing exercises, music, aromatherapy, or virtual reality is administered during this session. The participant is instructed to remain seated with eyes open maintaining a natural posture without engaging in any structured activity.

06

What researchers measure

Primary outcomes

  1. Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed)

    Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from resting-state EEG recordings collected during eyes-open and eyes-closed conditions. Spectral power will be calculated separately for eyes-open and eyes-closed resting-state conditions.

    Time frame: Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period

  2. Heart Rate Variability (HRV)

    HRV will be recorded at three time points. Baseline HRV will be calculated as the average over a 5-minute resting-state period immediately before intervention. HRV during the intervention will be calculated as the average over the entire intervention session (periprocedural). Post-intervention HRV will be calculated as the average over a 5-minute resting-state period immediately after intervention.

    Time frame: Baseline (average over 5-minute resting-state immediately before intervention); During intervention (average over entire session, periprocedural); Post-intervention (average over 5-minute resting-state immediately after intervention).

Secondary outcomes

  1. Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during N-back task

    Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from EEG recordings collected during performance of the N-back cognitive task. Spectral power will be calculated separately for each frequency band and averaged across all EEG channels.

    Time frame: Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural)

  2. Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during intervention session

    Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from EEG recordings collected during the intervention session. Spectral power will be calculated separately for each frequency band and averaged across all EEG channels.

    Time frame: During intervention session (periprocedural, averaged over entire session).

  3. Perceived Stress measured with the Subjective Units of Distress Scale (SUDS)

    The participant rates their perceived stress using the Subjective Units of Distress Scale (SUDS), a self-reported scale ranging from 0 (no stress) to 100 (extreme stress), where higher scores indicate higher perceived stress.

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session

  4. Cognitive Performance (N-back)

    Working memory assessed using N-back test with Emotiv app.

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.

  5. Blood Pressure

    Systolic and diastolic blood pressure measured using standard protocols.

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session

  6. Pain Threshold

    Pain threshold measured using a dolorimeter (algorimeter).

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.

  7. Positive and Negative Affect measured with the Positive and Negative Affect Schedule - Short Form (PANAS-SF)

    The participant completes the Positive and Negative Affect Schedule - Short Form (PANAS-SF), a self-reported scale assessing positive and negative affect. Each subscale contains 10 items rated from 1 (very slightly or not at all) to 5 (extremely), giving a possible score range of 10-50 for each subscale. Higher scores indicate higher levels of positive or negative affect, depending on the subscale.

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session

  8. Heart Rate

    Heart rate measured using standard protocols.

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.

Other outcomes

  1. Psychological Well-Being measured with the Short Version of Ryff's Psychological Well-Being Scale

    The participant completes the Short Version of Ryff's Psychological Well-Being Scale, a self-reported questionnaire assessing psychological well-being across multiple dimensions. Items are rated on a scale from 1 (strongly disagree) to 6 (strongly agree), giving a total possible score range of 18-108, where higher scores indicate higher levels of psychological well-being.

    Time frame: Day before first intervention.

  2. Trait Mindfulness measured with the Mindful Attention Awareness Scale (MAAS)

    The participant completes the Mindful Attention Awareness Scale (MAAS), a self-reported questionnaire measuring trait mindfulness. Items are rated on a scale from 1 (almost always) to 6 (almost never), with total scores ranging from 15 to 90. Higher scores indicate higher levels of trait mindfulness.

    Time frame: Day before first intervention.

  3. Coping with Stress measured with the Brief COPE Inventory (mini-COPE)

    The participant completes the Brief COPE Inventory (mini-COPE), a self-reported questionnaire assessing coping strategies and stress management. Each item is rated on a scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot), with total subscale scores ranging from 2 to 8, depending on the subscale. Higher scores indicate greater use of the specific coping strategy.

    Time frame: Day before first intervention.

  4. Chronotype measured with the Morningness-Eveningness Questionnaire (MEQ)

    The participant completes the Morningness-Eveningness Questionnaire (MEQ) to assess chronotype, indicating morningness-eveningness preference. Items are scored to give a total score ranging from 16 to 86, where higher scores indicate greater morningness and lower scores indicate greater eveningness.

    Time frame: Day before first intervention.

  5. Global Physical Activity measured with the Global Physical Activity Questionnaire (GPAQ)

    The participant completes the Global Physical Activity Questionnaire (GPAQ) to assess baseline physical activity levels. Responses are used to calculate total physical activity expressed in MET-minutes per week, with higher scores indicating higher levels of physical activity.

    Time frame: Day before first session.

  6. Sleep Quality and Duration (Pittsburgh Sleep Quality Index)

    The participant completes the Pittsburgh Sleep Quality Index (PSQI) to assess sleep quality and average sleep duration.

    Time frame: Day before first session.

  7. Objective Sleep and Physical Activity (Polar Ignite)

    The participant wears Polar Ignite wrist-worn device to monitor sleep quality and duration, as well as daily physical activity levels.

    Time frame: During the 1-week washout period between intervention sessions.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — This study involves a single participant. All relevant results will be reported in the published manuscript.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Oct 30, 2026→Apr 30, 2027
Nov 2, 2026
Study completion
Oct 30, 2026→Apr 30, 2027
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Primary completion Oct 30, 2026→Apr 30, 2027
    Study completion Oct 30, 2026→Apr 30, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07437833
Lead sponsor
Poznan University of Physical Education
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Jul 31, 2026
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Nov 2, 2026

Study contacts

Beata Jóźwiak
Contact
b.jozwiak@awf.poznan.pl
(61) 835 53 49
Ida Laudańska-Krzemińska
study director · Poznan University of Physical Education

Oversight

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

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