Postural Tachycardia SyndromeNCT00692471
Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)
An observational study of Postural Tachycardia Syndrome and Orthostatic Intolerance, run by Satish R. Raj at 1 site in United States.
Trial summary
We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Tachycardia Syndrome, Orthostatic Intolerance, Sleep Disorders
- What is being tested?
- Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2029
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with the Postural Tachycardia Syndrome. The criteria include: * an increase in heart rate on standing (from supine) of >30 bpm * in the setting of symptoms of cerebral hypoperfusion that are worse with standing and better when recumbent * the symptoms are daily or almost daily * the symptoms are chronic (lasting greater than 6 motnsh)
Who may be able to join
- Diagnosed with orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center
- Control subjects will be free of orthostatic intolerance and other major medical problems, free of medications during the study
- Age between 18-65 years
- Male and female subjects are eligible.
- Able and willing to provide informed consent
Who cannot join
- Overt cause for postural tachycardia (such as acute dehydration)
- Self-report of pregnancy
- Inability to give, or withdrawal of, informed consent
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University
Nashville, Tennessee, 37232-2195
About this study
Official title: Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy
We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.
Read the detailed description
We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.
- Being tested
- Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter
- Keywords
- Sleep, Orthostatic tachycardia, POTS
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actigraphy Watch (motion sensors) with light sensors - ActiWatch from MinimitterDevice
Also called ActiWatch from Minimitter
Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients meeting the diagnostic criteria for the Postural Tachycardia Syndrome, a form of Orthostatic Intolerance Receives: Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter | |
| 2 | Healthy control subjects who do not meet the criteria for the Postural Tachycardia Syndrome Receives: Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Latency
Measured: 1 week
Secondary outcomes (2)
Sleep Efficiency
Measured: 1 week
Wake After Sleep Onset
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Tachycardia SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satish R. Raj
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor-investigator, Satish R. Raj, Vanderbilt University Medical Center
- Investigators
- Satish R Raj, MD MSCI, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692471
- Sponsor's protocol ID
- 080233
- Other IDs
- K23RR020783
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2008
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy
- ClinicalTrials.gov ID
- NCT00692471
- Acronym / sponsor ID
- 080233
- Keywords
- Sleep, Orthostatic tachycardia, POTS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Satish R. RajUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jun 2008
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 Jun 2008 (estimated)
- 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.
We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.
Detailed description
We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from MinimitterPatients meeting the diagnostic criteria for the Postural Tachycardia Syndrome, a form of Orthostatic Intolerance |
| 2 | – | Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from MinimitterHealthy control subjects who do not meet the criteria for the Postural Tachycardia Syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with the Postural Tachycardia Syndrome. The criteria include: * an increase in heart rate on standing (from supine) of >30 bpm * in the setting of symptoms of cerebral hypoperfusion that are worse with standing and better when recumbent * the symptoms are daily or almost daily * the symptoms are chronic (lasting greater than 6 motnsh)
Key inclusion criteria (5 listed)
- Diagnosed with orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center
- Control subjects will be free of orthostatic intolerance and other major medical problems, free of medications during the study
- Age between 18-65 years
- Male and female subjects are eligible.
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- Overt cause for postural tachycardia (such as acute dehydration)
- Self-report of pregnancy
- Inability to give, or withdrawal of, informed consent
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol
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 |
|---|---|---|
| Actigraphy Watch (motion sensors) with light sensors - ActiWatch from MinimitterAlso: ActiWatch from MinimitterWatch to be worn on wrist for 7 days (except in water) that will measure activity/movement. | Device | 1, 2 |
Primary outcome
Sleep Latency
Time frame: 1 week
2 secondary outcomes
Sleep Efficiency
Time frame: 1 week
Wake After Sleep Onset
Time frame: 1 week
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 16 Oct 2026.
- Vanderbilt Autonomic Dysfunction Center WebsiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Satish R Raj, MD MSCI principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postural Tachycardia Syndrome and Orthostatic Intolerance, run by Satish R. Raj at 1 site in United States.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Latency (time frame: 1 week). 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 16 Oct 2026.