Evaluation in Patients With Obstructive Sleep Apnea That Had Undergone Diagnosis and Surgical Treatment

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

DISE is a safe procedure, easily practicable, valid and reliable. The investigators consider it a fundamental clinical procedure that is essential before choosing the surgical treatment. The investigator's results so far suggest that a multilevel collapse is significantly associated with higher apnea hypopnea index values. The investigators think that the weight did not play a significant role in RDI reduction. Results till now show that tailored surgery based on DISE may leverage sleep surgeries outcome significantly, presenting 70% success rate based on the investigator's experience The aim of this study is to evaluate surgery results in patients who underwent DISE prior to their surgery in comparison to their condition prior to the treatment.

Study Overview

• Status: Unknown
• Conditions: OSA
• Intervention / Treatment: Other: Retrospective review

Detailed Description

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

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. It is considered a fundamental clinical procedure that is essential before choosing the surgical treatment. Results so far suggest that a multilevel collapse is significantly associated with higher apnea hypopnea index values. The investigators think that the weight did not play a significant role in RDI reduction. Results till now show that tailored surgery based on DISE may leverage sleep surgeries outcome significantly, presenting 70% success rate based on the investigator's experience The aim of this tudy is to evaluate surgery results in patients who underwent DISE prior to their surgery in comparison to their condition prior to the treatment.

The results of the DISE based treatment will be compared with literature data from patients who underwent the surgery without DISE.

Method:

A retrospective follow-up study. Patients with snoring and OSA, had sleep study and had DISE before deciding on the surgical treatment. DISE findings were reported using the NOHL and VOTE classifications systems; site, degree of airway narrowing and configuration of obstruction. Patients underwent tailored surgery based on DISE findings included multi-level surgery; palate, tonsils, base of tongue and epiglottis.

After examining the results of the surgery in the patients, a comparison will be made based on sleep laboratory parameters (RDI, minimum saturation, degree of sleep apnea, degree of snoring) with data from the literature for patients who did not undergo DISE. On the whole, the degree of improvement in the patient's condition will be assessed.

We would like to show preference in surgery outcome in patients who were diagnosed using DISE.

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with snoring and OSA.

Description

Inclusion Criteria:

• Age 18-90
• Female or Male
• Fully diagnosed patients with OSA (including sleep laboratory) who are candidates for surgery as a treatment for their condition.

Exclusion Criteria:

• Patients who are not candidates for surgery as a treatment for their OSA.
• Patients with high surgical risk.
• Patients with hematological and oncological background.
• Pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Respiratory Disturbance Index (RDI)	12 months
minimum saturation	12 month
degree of sleep apnea	12 month
degree of snoring	12 month

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: November 10, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (ESTIMATE): November 30, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2016
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 0052-16-HYMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED