NCT00936273

Brief Summary

The purpose of this study is to determine the double loop index (DLI) threshold with optimal sensitivity and specificity. The investigators hypothesize that the DLI gives a better reflection of the pathophysiology of the disease than the apnea-hypopnea-index (AHI).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

First QC Date

July 9, 2009

Last Update Submit

July 9, 2009

Conditions

Sleep Apnea Syndrome

Keywords

Sleep apnea syndromeSASdouble loop gainDLIdouble loop indexperiodic breathingpolysomnography

Outcome Measures

Primary Outcomes (1)

  • To determine DLI threshold with optimal sensitivity and specificity. The DLI threshold is the DLI value above which the test is considered positive. The optimal DLI threshold will be taken as the value that gives the highest area under the ROC curve.

    1 year

Secondary Outcomes (2)

  • To test the hypothesis that the sensitivity and specificity of the screening are higher when the DLI is used instead of the AHI

    1 year

  • To assess the repeatability of the DLI using home and in-hospital recordings of nasal pressure and saturation (SaO2).

    1 year

Study Arms (1)

Suspected sleep apnea syndrome

Outpatients with suspected sleep apnea syndrome, age \> 18 year

Eligibility Criteria

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

Outpatients suspected for sleep apnea syndrome

You may qualify if:

  • Suspected sleep apnea syndrome
  • \> 18 yr
  • Outpatient
  • Able and willing to use the necessary equipment for registration of nasal pressure and O2 saturation at home

You may not qualify if:

  • hospitalized patients
  • \< 18 yr
  • Not able to use the necessary equipment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center Alkmaar

Alkmaar, Wilhelminalaan 12, 1815 JD, Netherlands

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • J.G. van den Aardweg, dr

    Medical Center Alkmaar

    STUDY DIRECTOR

Central Study Contacts

J.G. van den Aardweg, Dr.

CONTACT

+3172-5482750j.g.vanden.aardweg@mca.nl

Study Design

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

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 10, 2009

Study Start

June 1, 2009

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

NL(1)