NCT00581022

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

10.1 years

First QC Date

December 22, 2007

Last Update Submit

August 9, 2018

Conditions

Postural Tachycardia SyndromeChronic Orthostatic Intolerance

Keywords

postural tachycardia syndromesleepinsomnia

Outcome Measures

Primary Outcomes (1)

  • Duration of sleep

    1 night

Secondary Outcomes (2)

  • Time in individual phases of sleep

    1 night

  • sleep latency

    1 might

Study Arms (1)

1

Patients with Chronic Orthostatic Intolerance

Procedure: Polysomnography

Interventions

PolysomnographyPROCEDURE

Overnight Sleep Study

Also known as: Sleep Study
1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with chronic orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center

You may qualify if:

  • diagnosed with chronic orthostatic intolerance (or healthy subject)

You may not qualify if:

  • overt cause or acute orthostatic intolerance
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Unviersity

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia SyndromeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Satish R Raj, MD MSCI

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine & Pharmacology

Study Record Dates

First Submitted

December 22, 2007

First Posted

December 27, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)