Sleep Actigraphy in Postural Tachycardia Syndrome (POTS) | NCT00692471

Studies
Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

NCT00692471

Sponsor

Satish R. Raj

Status

Active, not recruiting

Last Update Posted

Oct 8, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Postural Tachycardia Syndrome
Orthostatic Intolerance
Sleep Disorders

Interventions

Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter

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
K23RR020783	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Jun 2, 2008

First Submission Date that Met QC Criteria

Jun 5, 2008

First Posted Date

Jun 6, 2008Estimated

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

Oct 3, 2025

Last Update Posted Date

Oct 8, 2025Actual

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 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

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 meeting the diagnostic criteria for the Postural Tachycardia Syndrome, a form of Orthostatic Intolerance	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	Device: Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter	Device	Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.

Measure	Description	Time Frame
Sleep Latency		1 week

Measure	Description	Time Frame
Sleep Efficiency		1 week
Wake After Sleep Onset		1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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 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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University		Nashville	Tennessee	37232-2195	United States

Label	URL
Vanderbilt Autonomic Dysfunction Center Website	View source

Condition Browse Module

MeSH Terms

ID	Term
D054972	Postural Orthostatic Tachycardia Syndrome
D054971	Orthostatic Intolerance
D012893	Sleep Wake Disorders

Ancestor Terms

ID	Term
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

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