NCT02976207

Brief Summary

Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical treatment

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

November 8, 2016

Last Update Submit

November 29, 2016

Conditions

OSA

Outcome Measures

Primary Outcomes (2)

  • Measurement of daytime sleepiness- using Epworth sleepiness scale questionnaire

    up to 3 years after surgery

  • Sleep quality assessment questionnaire

    up to 3 years after surgery

Study Arms (1)

OSA diagnosed patients

patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition.

You may qualify if:

  • Fully diagnosed patients with OSA.
  • Patients who are candidates for a surgery as a treatment to their condition.

You may not qualify if:

  • Pregnancy
  • Patients who are not OSA surgery candidates.
  • Patients with high surgical risk.
  • Patients with hematological or oncological background.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yafe medical center

Hadera, Hadera, Israel

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 29, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Last Updated

November 30, 2016

Record last verified: 2016-11

Locations

IL(1)