NCT02740569

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

April 6, 2016

Last Update Submit

September 6, 2018

Conditions

Scleroderma, SystemicSleep Apnea, ObstructivePulmonary Disease

Keywords

sclerodermasleep apneapulmonary disease

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Occurrence of pulmonary involvement based on computer tomography findings

    6 months

Interventions

No interventionOTHER

Observational study. Intervention according to the clinical routines (not included in this part)

Eligibility Criteria

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

Consecutive patients with known Scleroderma

You may qualify if:

  • Known scleroderma diagnosis
  • Must be able to give informed consent

You may not qualify if:

  • Serious neurological and/or psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Pendik, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 32285251DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for metabolic and cardiovascular markers

MeSH Terms

Conditions

Scleroderma, SystemicSleep Apnea, ObstructiveLung DiseasesScleroderma, DiffuseSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Yuksel Peker, MD, Prof

    Marmara University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 15, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

TU(1)