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

H

Hillel Yaffe Medical Center

Status

Unknown

Conditions

OSA

Treatments

Other: Retrospective review

Study type

Observational

Funder types

Other

Identifiers

NCT02977338
0052-16-HYMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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