NCT01175421

Brief Summary

Purpose: In a retrospective cohort the investigators will validate, the goodness of a multidimensional index to classified the severity of patients with sleep disordered breathing that has been previously developed in a prospective longitudinal cohort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Typical duration 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

May 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 23, 2015

Status Verified

August 1, 2010

Enrollment Period

3 years

First QC Date

August 3, 2010

Last Update Submit

March 19, 2015

Conditions

SnoringSleep Apnea

Keywords

snoringsleep apneasleep studycardiovascular outcomes

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Five years

Secondary Outcomes (1)

  • Cardiovascular events

    Five years

Study Arms (1)

Patients undergoing sleep study

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sleep Clinic

You may qualify if:

  • Adults patients (\> 18 years)

You may not qualify if:

  • Under 18 years old
  • Unable to complete sleep study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Miguel Servet

Zaragoza, 50190, Spain

Location

MeSH Terms

Conditions

SnoringSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jose M Marin, M.D.

    Hospital Miguel Servet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 4, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 23, 2015

Record last verified: 2010-08

Locations

ES(1)