Objective Sleep Disturbances in Orthostatic Intolerance | NCT00581022

Studies
Objective Sleep Disturbances in Orthostatic Intolerance

NCT00581022

Sponsor

Satish R. Raj

Status

Completed

Last Update Posted

Aug 10, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Postural Tachycardia Syndrome
Chronic Orthostatic Intolerance

Interventions

Polysomnography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UL1RR024975	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Dec 22, 2007

First Submission Date that Met QC Criteria

Dec 22, 2007

First Posted Date

Dec 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2018

Last Update Posted Date

Aug 10, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University Medical CenterSponsor-Investigator

Lead Sponsor

Satish R. RajOTHER

Collaborators

Name	Class
National Center for Research Resources (NCRR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with Chronic Orthostatic Intolerance	Procedure: Polysomnography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polysomnography	Procedure	Overnight Sleep Study	1	Sleep Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of sleep		1 night

Secondary Outcomes

Measure	Description	Time Frame
Time in individual phases of sleep		1 night
sleep latency		1 might

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosed with chronic orthostatic intolerance (or healthy subject)

Exclusion Criteria:

overt cause or acute orthostatic intolerance
pregnancy or lactation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Satish R Raj, MD MSCI	Vanderbilt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt Unviersity		Nashville	Tennessee	37232	United States

Condition Browse Module

MeSH Terms

ID	Term
D054972	Postural Orthostatic Tachycardia Syndrome
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D054971	Orthostatic Intolerance
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided