Postural Tachycardia Syndrome Clinical Trial
Official title:
Alterations of Attention in Patients With Postural Tachycardia Syndrome and Healthy Controls Depending on Body Position and Hydration
Verified date | July 2022 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Postural Tachycardia-Syndrome (POTS) is a form of autonomic dysregulation, typically accompanied by symptoms of orthostatic intolerance (OI). OI is defined by the inability to tolerate the upright position and is improved by lying down. POTS is considered a syndrome that may include a number of several disorders. Symptoms should be persistent for at least 6 months to reach a diagnosis. It is characterized by a sustained heart rate (HR) increment of 30 beats/min or more within 10 min of standing or head-up tilt (HUT) in adults, in the absence of orthostatic hypotension and with the presence of symptoms of OI. In children and adolescents a diagnosis requests a HR increment of at least 40 beats/min. The increment in HR when moving to an upright posture is often a response to a reduction in venous return, causing excessive blood pooling in the lower limbs. The symptoms present in POTS vary greatly. Typical symptoms are lightheadedness, dizziness, blurred vision, mental clouding ("brain fog") or cognitive dysfunction. Other symptoms may present as palpitations or chest pain. Additional symptoms consist of postural headaches, nausea, sleep disturbances, fatigue and gastrointestinal dysfunction. The manifestation of symptoms in POTS varies in severity, frequency and combination, resulting in POTS being a very heterogenous and subjective disorder. Symptoms can be severe and often make simple daily activities difficult to an extent that compromises the patients quality of life. Typically symptoms exacerbate in the mornings, after physical activity, after eating and during menstruation. This study objective is to examine the occurrence, mechanisms and causes of impaired attention in POTS as well as to test the effect of acute water ingestion for attention in POTS. The investigators therefore conduct a study including patients with POTS and healthy volunteers. All participants will receive a dossier of five self-assessment questionnaires after giving informed consent. Clinical examination includes 2 HUT-tests while standing for 15 minutes, conventional measuring of blood pressure, continuous recording of NIRS signals during testing, determination of pupil size, the diameter of the optic nerve and Neuropsychological testing (Test of Attentional Performance, mobility version" (TAP-M), Go/NoGo Test, Divided Attention Test)
Status | Completed |
Enrollment | 30 |
Est. completion date | July 5, 2022 |
Est. primary completion date | April 14, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: For patients: - Informed consent - Patients with diagnosed POTS (for criteria, see above) - Age: =18 years and = 60 years For healthy volunteers: - Informed consent - Age: =18 years and = 60 years Exclusion Criteria: For patients: - Pregnancy and Breastfeeding - Due to clinical reasons the current medication for POTS can not be discontinued For healthy volunteers: - Pregnancy and Breastfeeding - Intake of vasoactive medication or known, non-treated arterial hypertension - Known vasovagal syncope in medical history |
Country | Name | City | State |
---|---|---|---|
Switzerland | Inselspital Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Anderson JW, Lambert EA, Sari CI, Dawood T, Esler MD, Vaddadi G, Lambert GW. Cognitive function, health-related quality of life, and symptoms of depression and anxiety sensitivity are impaired in patients with the postural orthostatic tachycardia syndrome (POTS). Front Physiol. 2014 Jun 25;5:230. doi: 10.3389/fphys.2014.00230. eCollection 2014. — View Citation
Arnold AC, Haman K, Garland EM, Raj V, Dupont WD, Biaggioni I, Robertson D, Raj SR. Cognitive dysfunction in postural tachycardia syndrome. Clin Sci (Lond). 2015 Jan;128(1):39-45. doi: 10.1042/CS20140251. — View Citation
Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, Goldstein DS, Hainsworth R, Hilz MJ, Jacob G, Kaufmann H, Jordan J, Lipsitz LA, Levine BD, Low PA, Mathias C, Raj SR, Robertson D, Sandroni P, Schatz I, Schondorff R, Stewart JM, van Dijk JG. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011 Apr;21(2):69-72. doi: 10.1007/s10286-011-0119-5. — View Citation
Lambert E, Lambert GW. Sympathetic dysfunction in vasovagal syncope and the postural orthostatic tachycardia syndrome. Front Physiol. 2014 Jul 28;5:280. doi: 10.3389/fphys.2014.00280. eCollection 2014. Review. — View Citation
Ocon AJ, Messer ZR, Medow MS, Stewart JM. Increasing orthostatic stress impairs neurocognitive functioning in chronic fatigue syndrome with postural tachycardia syndrome. Clin Sci (Lond). 2012 Mar;122(5):227-38. doi: 10.1042/CS20110241. — View Citation
Raj SR. Postural tachycardia syndrome (POTS). Circulation. 2013 Jun 11;127(23):2336-42. doi: 10.1161/CIRCULATIONAHA.112.144501. Review. — View Citation
Z'Graggen WJ, Hess CW, Humm AM. Acute fluid ingestion in the treatment of orthostatic intolerance - important implications for daily practice. Eur J Neurol. 2010 Nov;17(11):1370-6. doi: 10.1111/j.1468-1331.2010.03030.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Scores of the questionnaires (composite endpoint) | Beck's Depression Inventory II (BDI-II) for assessing depression, Short Form (36) Health Survey (SF-36) for assessing health-related quality of life, Pittsburgh Sleep Quality Index (PSQI) for assessing sleep quality, International Physical Activity Questionaire | Through study completion an average of 1 day | |
Primary | Numerical variables reaction time and/or hits resp. misses in the subtests "alertness" from the automated test battery "Test of Attentional Performance, mobility version" | "Alertness" is designed to assess tonic alertness, which is defined as the ability to maintain a high level of responsiveness in anticipation of a test stimulus. The alertness test measures the simple reaction time in response to a visual stimulus (a cross presented on the monitor) | After change body position and 5dl of water, up to 30 minutes | |
Primary | Numerical variables reaction time and/or hits resp. misses in the subtest "Go/NoGo" from the automated test battery "Test of Attentional Performance, mobility version" | The "Go/NoGo" task for assessing the specific ability of subjects to suppress undesired responses. Reaction times and errors are recorded in a simple test with two stimuli | After change body position and 5dl of water, up to 30 minutes | |
Primary | Numerical variables reaction time and/or hits resp. misses in the subtest "divided attention" from the automated test battery "Test of Attentional Performance, mobility version" | In the Test of Attentional Performance a visual and an auditory task must be processed in parallel | After change body position and 5dl of water, up to 30 minutes | |
Secondary | Diameter of the optic nerve | The diameter of the optic nerve is measured with a 7-15 MHz linear array transducer in transorbital B-mode ultrasound . | After change body position and 5dl of water, up to 30 minutes | |
Secondary | Brain perfusion measured with NIRS | All parameters of brain perfusion will be assessed using NIRS. | After change body position and 5dl of water, up to 30 minutes | |
Secondary | Heart rate | For autonomic function testing, beat-to-beat BP and HR are measured with the Finometer device. | After change body position and 5dl of water, up to 30 minutes | |
Secondary | Blood pressure | For autonomic function testing, beat-to-beat BP and HR are measured with the Finometer device. | After change body position and 5dl of water, up to 30 minutes | |
Secondary | Pupil diameter | Determination of pupil size will be performed with a rubber cup covering the measured eye and the operator's hand covering the nonmeasured eye. A brief 2- to 3-second pause allows the pupil to dilate briefly at which time the measurement will be taken. Pupil size is the average diameter for the entire measurement time, which is typically 3 to 4 seconds. | After change body position and 5dl of water, up to 30 minutes |
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