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

OSA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02977338
• Other study ID #: 0052-16-HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 10, 2016
• Last updated: December 1, 2016
• Start date: December 2016
• Est. completion date: December 2017

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• OSA
• Sleep Apnea, Obstructive

Intervention

Other:
• Retrospective review

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Disturbance Index (RDI)		12 months	No
Primary	minimum saturation		12 month	No
Primary	degree of sleep apnea		12 month	No
Primary	degree of snoring		12 month	No