Sleep Disturbances and Pulmonary Artery/Aorta Diameter in... | NCT00566137

Studies
Sleep Disturbances and Pulmonary Artery/Aorta Diameter in Scleroderma Patient

NCT00566137

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Mar 9, 2010Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Scleroderma
Pulmonary Hypertension

Interventions

Not provided

Countries

Not provided

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
NS-LIJHS IRB #06-08-018

Status Module

Record Verification Date

Mar 2010

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

Feb 2006

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Nov 29, 2007

First Submission Date that Met QC Criteria

Nov 30, 2007

First Posted Date

Dec 3, 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

Mar 8, 2010

Last Update Posted Date

Mar 9, 2010Estimated

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

To determine sleep disturbance, pulmonary function test, 6 minute walk, echocardiogram abnormality, arterial blood gas, ventilation/perfusion scan of the chest in Scleroderma patient with Pulmonary Hypertension.

Detailed Description

As above

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

50Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient must have Scleroderma

Exclusion Criteria:

Patients who do not have Scleroderma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Males, Females and Minorities

Age range of subjects 18-75 years old

Sampling Method

Probability Sample

Name	Affiliation	Role
Arunabh Talwar, MD	Northwell Health	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D045743	Scleroderma, Diffuse
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D012595	Scleroderma, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided