Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Diagnostic Test: Determination of optimal cutoff values.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
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
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
All patients
All patients included in the present study
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Adequacy of OSA50 to detect severe hypoxemic OSA patients [ Time Frame: One week ]
    Adequacy of OSA50 after comparison with the results of the PSG.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients scheduled to have a PSG in the sleep laboratory center.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047941


Locations
Layout table for location information
Belgium
ASTES
Bouge, Namur, Belgium, 5001
Sponsors and Collaborators
Astes

Additional Information:

Layout table for additonal information
Responsible Party: Eric DEFLANDRE, MD, PhD, FCCP, Principal Investigators, Astes
ClinicalTrials.gov Identifier: NCT03047941     History of Changes
Other Study ID Numbers: REES2
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases