Alterations of Attention in POTS Depending on Body Position and Hydration

NCT03253120 | Completed

• 1 other identifier: 2017-01368
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Postural Tachycardia Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Diameter of the optic nerve

  After change body position and 5dl of water, up to 30 minutes

• Brain perfusion measured with NIRS

  After change body position and 5dl of water, up to 30 minutes

• Heart rate

  After change body position and 5dl of water, up to 30 minutes

• Blood pressure

  After change body position and 5dl of water, up to 30 minutes

• Pupil diameter

  After change body position and 5dl of water, up to 30 minutes

Other Outcomes (1)

• Scores of the questionnaires (composite endpoint)

  Through study completion an average of 1 day

Study Arms (2)

Patient

OTHER

Patients will drink 5dl of water.

Other: Water

Healthy volunteer

OTHER

Healthy volunteers will drink 5dl of water.

Other: Water

Interventions

Water OTHER

Patient/ Healthy volunteer will drink 5dl of Water

Healthy volunteer; Patient

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern

Bern, 3010, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 25009504 BACKGROUND

• 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.

  PMID: 25001527 BACKGROUND

• 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. No abstract available.

  PMID: 21431947 BACKGROUND

• 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.

  PMID: 25120493 BACKGROUND

• 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.

  PMID: 21919887 BACKGROUND

• Raj SR. Postural tachycardia syndrome (POTS). Circulation. 2013 Jun 11;127(23):2336-42. doi: 10.1161/CIRCULATIONAHA.112.144501. No abstract available.

  PMID: 23753844 BACKGROUND

• 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.

  PMID: 20412295 BACKGROUND

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Water

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Werner Z'Graggen, MD

  Inselspital Bern, Department of Neurosurgery and Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will drink 5dl of water. Healthy volunteers will drink 5dl of water.

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 17, 2017
• Study Start: September 11, 2017
• Primary Completion: April 14, 2022
• Study Completion: July 5, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)