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

• Conditions: OSA

• Registration Number: NCT02976207
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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

Detailed 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

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-24
• Study First Posted: 2016-11-29
• Last Update Submitted: 2016-11-29
• Last Update Posted: 2016-11-30
• Study Start: 2017-01
• Primary Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hillel Yafe medical center; 🇮🇱 Hadera, Israel