ADHD - Attention Deficit Disorder With HyperactivityNCT07437833
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
A study testing Moderate-Intensity Aerobic Exercise on Cycloergometer, Cyclic Sighing and Aromatherapy in people with ADHD - Attention Deficit Disorder With Hyperactivity and Bipolar Affective Disorder; Remission in, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity, Bipolar Affective Disorder; Remission in
- What is being tested?
- Moderate-Intensity Aerobic Exercise on Cycloergometer, Cyclic Sighing and Aromatherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 sitePoland
- Study dates
- 31 Jul 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Contraindications 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, hypersensitivity to conductive gels or pastes).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Physical Education
Poznan
Szerment, (61) 835 51 12, szerment@awf.poznan.pl
About this study
Official title: Psychophysiological Responses to Six 15-Minute Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder: A Single-Case Study
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.
Read more
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.
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity, Bipolar Affective Disorder; Remission in
- Being tested
- Moderate-Intensity Aerobic Exercise on Cycloergometer, Cyclic Sighing, Aromatherapy, Music Therapy, Virtual Reality Nature Immersion
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Aerobic Exercise on CycloergometerBehavioural
Also called Physical Exercise
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.
Cyclic SighingBehavioural
Also called Breathing Exercises
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.
AromatherapyBehavioural
Also called Lavender Essential Oil Inhalation
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.
Music TherapyBehavioural
Also called Solfeggio 528 Hz Frequency Music Exposure
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.
Virtual Reality Nature ImmersionBehavioural
Also called VR Relaxation
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.
Emotional Freedom Technique TappingBehavioural
Also called Tapping on Acupuncture Points
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.
Resting State (Control Session)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| All Interventions and Control Session - Single Participant | Other | 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period
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.
Measured: 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 (8)
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.
Measured: Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural)
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.
Measured: During intervention session (periprocedural, averaged over entire session).
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.
Measured: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
Cognitive Performance (N-back)
Working memory assessed using N-back test with Emotiv app.
Measured: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
Blood Pressure
Systolic and diastolic blood pressure measured using standard protocols.
Measured: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
Pain Threshold
Pain threshold measured using a dolorimeter (algorimeter).
Measured: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
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.
Measured: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
Heart Rate
Heart rate measured using standard protocols.
Measured: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start31 Jul 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This case study involves one participant who will receive six different 15-minute self-regulation interventions and one control session (quiet sitting) in separate weekly sessions. Each intervention is delivered once, and all measurements are taken before and after each session.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ida Laudańska-Krzemińska, Study director, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437833
- Sponsor's protocol ID
- 716/25_2
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study involves a single participant. All relevant results will be reported in the published manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Responses to Six 15-Minute Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder: A Single-Case Study
- ClinicalTrials.gov ID
- NCT07437833
- Acronym / sponsor ID
- 716/25_2
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity, Bipolar Affective Disorder; Remission in
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This case study involves one participant who will receive six different 15-minute self-regulation interventions and one control session (quiet sitting) in separate weekly sessions. Each intervention is delivered once, and all measurements are taken before and after each session.
| Arm | Type | Receives |
|---|---|---|
| All Interventions and Control Session - Single Participant | Other | 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)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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Contraindications to moderate-intensity exercise on a cycle ergometer (e.g., recent injuries, chronic musculoskeletal conditions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-Intensity Aerobic Exercise on CycloergometerAlso: Physical ExerciseThe 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. | Behavioural | All Interventions and Control Session - Single Participant |
| Cyclic SighingAlso: Breathing ExercisesThe 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. | Behavioural | All Interventions and Control Session - Single Participant |
| AromatherapyAlso: Lavender Essential Oil InhalationThe 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. | Behavioural | All Interventions and Control Session - Single Participant |
| Music TherapyAlso: Solfeggio 528 Hz Frequency Music ExposureThe 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. | Behavioural | All Interventions and Control Session - Single Participant |
| Virtual Reality Nature ImmersionAlso: VR RelaxationThe 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. | Behavioural | All Interventions and Control Session - Single Participant |
| Emotional Freedom Technique TappingAlso: Tapping on Acupuncture PointsThe 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. | Behavioural | All Interventions and Control Session - Single Participant |
| Resting 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. | Behavioural | All Interventions and Control Session - Single Participant |
Primary outcome
Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed)
Time frame: Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period
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.
Heart Rate Variability (HRV)
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).
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.
8 secondary outcomes
Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during N-back task
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)
Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during intervention session
Time frame: During intervention session (periprocedural, averaged over entire session).
Perceived Stress measured with the Subjective Units of Distress Scale (SUDS)
Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
Cognitive Performance (N-back)
Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
Blood Pressure
Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
Pain Threshold
Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
Positive and Negative Affect measured with the Positive and Negative Affect Schedule - Short Form (PANAS-SF)
Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
Heart Rate
Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. This study involves a single participant. All relevant results will be reported in the published manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ida Laudańska-Krzemińska study director
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Aerobic Exercise on Cycloergometer, Cyclic Sighing and Aromatherapy in people with ADHD - Attention Deficit Disorder With Hyperactivity and Bipolar Affective Disorder; Remission in, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beata Jóźwiak ((61) 835 53 49, b.jozwiak@awf.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed) (time frame: Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.