Clinical trial NCT02977338: Evaluation in Patients With Obstructive Sleep Apnea That Had Undergone Diagnosis and Surgical Treatment
Official title: Evaluation in Patients With Obstructive Sleep Apnea That Had Undergone Diagnosis and Surgical Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: OSA
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with snoring and OSA.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Disturbance Index (RDI)
timeFrame: 12 months
measure: minimum saturation
timeFrame: 12 month
measure: degree of sleep apnea
timeFrame: 12 month
measure: degree of snoring
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: