Long Follow up on Patients With Obstructive Sleep Apnea That Undergo Diagnosis and Surgical Treatment

OSA Clinical Trial

— OSA  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02976207
• Other study ID #: 55-2015
• Status: Not yet recruiting
• Phase: N/A
• First received: November 8, 2016
• Last updated: November 29, 2016
• Start date: January 2017

Study information

• Verified date: November 2016
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

Drug induced sleep endoscopy (DISE) is increasingly performed procedure, offering dynamic upper airway evaluation during artificial sleep before surgical treatment for patients with obstructed

.)OSA(sleep apnea

• Aim: To evaluate the value of DISE for tailoring the proper treatment for patients with snoring and OSA DISE is a safe procedure, easily practicable, valid and reliable. We consider it a fundamental clinical procedure that is essential before choosing the surgical treatment. Our results so far suggest that a multilevel collapse is significantly associated with higher apnea hypopnea index values. We think that the weight did not play a significant role in RDI (Respiratory Disturbance Index) reduction. Our results till now show tailored surgery based on DISE may leverage sleep surgeries outcome significantly presenting 70% success rate based

• on our experience We therefore want to evaluate the patients in a long follow up period

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Fully diagnosed patients with OSA.

• Patients who are candidates for a surgery as a treatment to their condition.

Exclusion Criteria:

• Pregnancy

• Patients who are not OSA surgery candidates.

• Patients with high surgical risk.

• Patients with hematological or oncological background.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• OSA

Locations

Country	Name	City	State
Israel	Hillel Yafe medical center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of daytime sleepiness- using Epworth sleepiness scale questionnaire		up to 3 years after surgery	No
Primary	Sleep quality assessment questionnaire		up to 3 years after surgery	No