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Determination of Optimal Cutoff Value for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients

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ClinicalTrials.gov Identifier: NCT03047941
Recruitment Status : Suspended (Lack of participants)
First Posted : February 9, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Eric DEFLANDRE, MD, PhD, FCCP, Astes

Tracking Information
First Submitted Date February 6, 2017
First Posted Date February 9, 2017
Last Update Posted Date November 14, 2018
Actual Study Start Date February 13, 2017
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2017)
  • Adequacy of STOP-Bang to detect severe hypoxemic OSA patients [ Time Frame: One week. ]
    Adequacy of STOP-Bang after comparison with the results of the PSG.
  • Adequacy of P-SAP to detect severe hypoxemic OSA patients [ Time Frame: One week ]
    Adequacy of P-SAP after comparison with the results of the PSG.
  • Adequacy of OSA50 to detect severe hypoxemic OSA patients [ Time Frame: One week ]
    Adequacy of OSA50 after comparison with the results of the PSG.
  • Adequacy of DES-OSA to detect severe hypoxemic OSA patients [ Time Frame: One week ]
    Adequacy of DES-OSA after comparison with the results of the PSG.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03047941 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determination of Optimal Cutoff Value for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients
Official Title Determination of Optimal Cutoff Value of 4 Tests (DES-OSA, STOP-Bang, OSA50, P-SAP) for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients
Brief Summary

The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA, STOP-Bang, P-SAP, and OSA50.

The aim of this study is to evaluate the optimal cutoff value of these four scores to detect specifically serve OSA patients with hypoxemia.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients scheduled to have a PSG in the sleep laboratory center.
Condition Sleep Apnea, Obstructive
Intervention Diagnostic Test: Determination of optimal cutoff values.
The results of the four scores will be compared with the results of the polysomnography (PSG). A statistical analysis will be performed to determine the optimal cutoff value of each of the four scores to detect severe OSA patient with hypoxemia.
Study Groups/Cohorts All patients
All patients included in the present study
Intervention: Diagnostic Test: Determination of optimal cutoff values.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: February 8, 2017)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients scheduled to have a PSG in the sleep laboratory center.

Exclusion Criteria:

  • Patients < 18 years
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03047941
Other Study ID Numbers REES2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Eric DEFLANDRE, MD, PhD, FCCP, Astes
Study Sponsor Astes
Collaborators Not Provided
Investigators Not Provided
PRS Account Astes
Verification Date November 2018