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

NCT02977338 | Unknown

• 1 other identifier: 0052-16-HYMC
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

OSA

Outcome Measures

Primary Outcomes (4)

• Respiratory Disturbance Index (RDI)

  12 months

• minimum saturation

  12 month

• degree of sleep apnea

  12 month

• degree of snoring

  12 month

Interventions

Retrospective review OTHER

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with snoring and OSA.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 30, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 2, 2016

Record last verified: 2016-12