Postural Tachycardia SyndromeNCT00581022
Objective Sleep Disturbances in Orthostatic Intolerance
An observational study of Postural Tachycardia Syndrome and Chronic Orthostatic Intolerance, run by Satish R. Raj at 1 site in United States.
Trial summary
We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will test the null hypothesis that there is no difference in time during the various phases of sleep between patients and 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, Chronic Orthostatic Intolerance
- What is being tested?
- Polysomnography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 chronic orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center
Who may be able to join
- diagnosed with chronic orthostatic intolerance (or healthy subject)
Who cannot join
- overt cause or acute orthostatic intolerance
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Objective Sleep Disturbances in Orthostatic Intolerance
We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will test the null hypothesis that there is no difference in time during the various phases of sleep between patients and healthy control subjects.
- Being tested
- Polysomnography
- Keywords
- postural tachycardia syndrome, sleep, insomnia
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyProcedure or surgery
Also called Sleep Study
Overnight Sleep Study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with Chronic Orthostatic Intolerance Receives: Procedure: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sleep
Measured: 1 night
Secondary outcomes (2)
Time in individual phases of sleep
Measured: 1 night
sleep latency
Measured: 1 might
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startNov 2006
- Primary completionDec 2016
- Study completionDec 2016
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
- Cohort
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581022
- Sponsor's protocol ID
- 051131
- Other IDs
- UL1RR024975
- Status last verified
- Aug 2018
- First submitted
- 22 Dec 2007
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Objective Sleep Disturbances in Orthostatic Intolerance
- ClinicalTrials.gov ID
- NCT00581022
- Acronym / sponsor ID
- 051131
- Keywords
- postural tachycardia syndrome, sleep, insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Satish R. RajUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Nov 2006
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Dec 2007 (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 wish to study sleep architecture in patients with chronic orthostatic intolerance. We will test the null hypothesis that there is no difference in time during the various phases of sleep between patients and healthy control subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: PolysomnographyPatients with Chronic Orthostatic Intolerance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with chronic orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center
Key inclusion criteria (1 listed)
- diagnosed with chronic orthostatic intolerance (or healthy subject)
Key exclusion criteria (2 listed)
- overt cause or acute orthostatic intolerance
- pregnancy or lactation
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 |
|---|---|---|
| PolysomnographyAlso: Sleep StudyOvernight Sleep Study | Procedure or surgery | 1 |
Primary outcome
Duration of sleep
Time frame: 1 night
2 secondary outcomes
Time in individual phases of sleep
Time frame: 1 night
sleep latency
Time frame: 1 might
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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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
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 Chronic 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 10 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of sleep (time frame: 1 night). 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 10 Aug 2018.