[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626607":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":62,"centralContacts":66,"locations":72,"responsibleParty":88,"collaborators":61,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":61,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":61,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":61,"overallStatus":110,"whyStopped":61,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":101},{"fullName":5,"class":6},"Poznan University of Physical Education","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"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.",[12,13,14,15,16,17,18],"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)",[20,27,33,39,45,51,57],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Moderate-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.",[9],[26],"Physical Exercise",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Cyclic 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.",[9],[32],"Breathing Exercises",{"type":21,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Aromatherapy","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.",[9],[38],"Lavender Essential Oil Inhalation",{"type":21,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Music 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.",[9],[44],"Solfeggio 528 Hz Frequency Music Exposure",{"type":21,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Virtual 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.",[9],[50],"VR Relaxation",{"type":21,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Emotional 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.",[9],[56],"Tapping on Acupuncture Points",{"type":21,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"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.",[9],null,[63],{"name":64,"affiliation":5,"role":65},"Ida Laudańska-Krzemińska","STUDY_DIRECTOR",[67],{"name":68,"role":69,"phone":70,"phoneExt":61,"email":71},"Beata Jóźwiak","CONTACT","(61) 835 53 49","b.jozwiak@awf.poznan.pl",[73],{"facility":5,"status":61,"city":74,"state":61,"zip":61,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Poznan","Poland","PL",{"type":78,"coordinates":79},"Point",[80,81],16.92993,52.40692,{"lat":81,"lon":80},[84],{"name":85,"role":69,"phone":86,"phoneExt":61,"email":87},"Szerment","(61) 835 51 12","szerment@awf.poznan.pl",{"type":89,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100626607","psychophysiological-responses-to-six-single-session-self-regulation-interventions-in-a-female-adult-with-adhd-and-stabilized-bipolar-disorder-100626607",false,"NCT07437833","Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder","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","Inclusion Criteria:\n\n* Diagnosis of ADHD and bipolar disorder (type I or II) in stable remission.\n* No active depressive, manic, or psychotic episodes for at least 2 years.\n* No use of psychotropic medications, including mood stabilizers, antidepressants, antipsychotics, or ADHD medications, for at least 2 years.\n* No chronic somatic diseases (including neurological, cardiovascular, or metabolic disorders).\n* Regular sleep-wake rhythm during the week preceding the study.\n* Non-smoker.\n* No night-shift work in the week preceding the study.\n\nExclusion Criteria:\n\n* Acute medical conditions that could affect study procedures.\n* Use of medications in the past 3 months that influence cardiovascular or neurological parameters.\n* Consumption of alcohol or psychoactive substances on the day before or day of the study.\n* Intense physical activity on the day before or day of the study.\n* Contraindications to moderate-intensity exercise on a cycle ergometer (e.g., recent injuries, chronic musculoskeletal conditions).\n* Contraindications to EEG measurement (e.g., scalp skin conditions preventing proper electrode placement, hypersensitivity to conductive gels or pastes).","FEMALE","18 Years","35 Years",{"count":101,"type":102},1,"ESTIMATED","INTERVENTIONAL",[105],"NA","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:\n\n* Aerobic exercise\n* Controlled breathing (cyclic sighing)\n* Aromatherapy with lavender essential oil\n* Listening to specific music (Solfeggio 528 Hz)\n* Virtual reality relaxation with forest imagery\n* Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison.\n\nThe participant will attend one 15-minute session per week for each technique. Before and after each session, the researchers will measure:\n\n* Heart rate and heart rate variability\n* Stress levels using Subjective Units of Distress Scale\n* Mood using a questionnaire\n* Blood pressure\n* Brain activity using EEG\n* Memory performance with a simple test (N-back)\n* 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.",[108,109],"ADHD - Attention Deficit Disorder With Hyperactivity","Bipolar Affective Disorder; Remission in","NOT_YET_RECRUITING","2026-02-23",{"date":113,"type":114},"2026-02-27","ACTUAL",{"date":116,"type":102},"2026-04-01",{"date":118,"type":102},"2026-08-31",{"name":5,"class":6}]