Obstructive Sleep Apnea in Scleroderma and Pulmonary Invo... | NCT02740569

Studies
Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

NCT02740569

Sponsor

Marmara University

Status

Completed

Last Update Posted

Sep 7, 2018Actual

Enrollment

62Actual

Phase

Not provided

Conditions

Scleroderma, Systemic
Sleep Apnea, Obstructive
Pulmonary Disease

Interventions

No intervention

Countries

Turkey (Türkiye)

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

Status Module

Record Verification Date

Sep 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

Apr 2016

Primary Completion Date

Oct 1, 2016Actual

Completion Date

Oct 1, 2016Actual

First Submitted Date

Apr 6, 2016

First Submission Date that Met QC Criteria

Apr 14, 2016

First Posted Date

Apr 15, 2016Estimated

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

Sep 6, 2018

Last Update Posted Date

Sep 7, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement.

Detailed Description

Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. OSA may also be seen in scleroderma. Less is known regarding the prevalence of obstructive sleep apnea in scleroderma and its association with pulmonary involvement.

The investigators would like to address the prevalence of OSA in patients with Scleroderma, using overnight cardiorespiratory polygraphy. Other comorbidities and pulmonary findings on computer tomography (CT) as well as lung function tests will be evaluated.

The investigators plan to include 60 patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	Observational study. Intervention according to the clinical routines (not included in this part)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of OSA defined by apnea-hypopnea index (AHI) of at least 15/h on the overnight sleep study	All participants will be evaluated within 6 months	6 months

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of pulmonary involvement based on computer tomography findings	All patients will be evaluated within 6 months	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Known scleroderma diagnosis
Must be able to give informed consent

Exclusion Criteria:

Serious neurological and/or psychiatric disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients with known Scleroderma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuksel Peker, MD, Prof	Marmara University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marmara University		Istanbul	Pendik		Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32285251	Derived	Yakut T, Balcan B, Karakurt S, Direskeneli H, Yalcinkaya Y, Peker Y. Impact of concomitant obstructive sleep apnea on pulmonary involvement and main pulmonary artery diameter in adults with scleroderma. Sleep Breath. 2021 Mar;25(1):135-143. doi: 10.1007/s11325-020-02059-4. Epub 2020 Apr 13.

ID	Term
D012595	Scleroderma, Systemic
D020181	Sleep Apnea, Obstructive
D008171	Lung Diseases
D045743	Scleroderma, Diffuse
D012891	Sleep Apnea Syndromes

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases
D001049	Apnea