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Alterations of Attention in POTS Depending on Body Position and Hydration

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ClinicalTrials.gov Identifier: NCT03253120
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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)


Condition or disease Intervention/treatment
Postural Tachycardia Syndrome Other: Water

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will drink 5dl of water. Healthy volunteers will drink 5dl of water.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alterations of Attention in Patients With Postural Tachycardia Syndrome and Healthy Controls Depending on Body Position and Hydration
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Patient
Patients will drink 5dl of water.
Other: Water
Patient/ Healthy volunteer will drink 5dl of Water
Healthy volunteer
Healthy volunteers will drink 5dl of water.
Other: Water
Patient/ Healthy volunteer will drink 5dl of Water


Outcome Measures

Primary Outcome Measures :
  1. Numerical variables reaction time and/or hits resp. misses in the subtests "alertness" from the automated test battery "Test of Attentional Performance, mobility version" [ Time Frame: After change body position and 5dl of water, up to 30 minutes ]
    "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)

  2. 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" [ Time Frame: After change body position and 5dl of water, up to 30 minutes ]
    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

  3. 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" [ Time Frame: After change body position and 5dl of water, up to 30 minutes ]
    In the Test of Attentional Performance a visual and an auditory task must be processed in parallel


Secondary Outcome Measures :
  1. Diameter of the optic nerve [ Time Frame: After change body position and 5dl of water, up to 30 minutes ]
    The diameter of the optic nerve is measured with a 7-15 MHz linear array transducer in transorbital B-mode ultrasound .

  2. Brain perfusion measured with NIRS [ Time Frame: After change body position and 5dl of water, up to 30 minutes ]
    All parameters of brain perfusion will be assessed using NIRS.

  3. Heart rate [ Time Frame: After change body position and 5dl of water, up to 30 minutes ]
    For autonomic function testing, beat-to-beat BP and HR are measured with the Finometer device.

  4. Blood pressure [ Time Frame: After change body position and 5dl of water, up to 30 minutes ]
    For autonomic function testing, beat-to-beat BP and HR are measured with the Finometer device.

  5. Pupil diameter [ Time Frame: After change body position and 5dl of water, up to 30 minutes ]
    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.


Other Outcome Measures:
  1. Scores of the questionnaires (composite endpoint) [ Time Frame: Through study completion an average of 1 day ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253120


Contacts
Contact: Werner Z`Graggen, MD +41316327909 werner.zgraggen@insel.ch
Contact: Nicole Söll +316323164 nicole.soell@insel.ch

Locations
Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Werner Z`Graggen, MD    +41 31 632 79 09    werner.zgraggen@insel.ch   
Contact: Nicole Söll    +41 31 632 00 14    nicole.soell@insel.ch   
Principal Investigator: Werner Z`Graggen, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Werner Z`Graggen, MD Inselspital Bern, Department of Neurosurgery and Neurology
More Information

Publications:

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03253120     History of Changes
Other Study ID Numbers: 2017-01368
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases