New Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome

Evaluation of Novel Drug Induced Sleep Endoscopy Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome

Drug-induced sleep endoscopy (DISE) used as diagnostic tool but not yet as a therapeutic procedures to manage the upper airway of snorers and obstructive sleep apnea patients in conditions that mimic natural sleep, there are many aspects that need to be standardized in order to obtain reliable and reproducible information result in cryotherapy at sites of vibration as origin of snoring and site of collapse.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Procedure: cryotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: fatma h mohamed, assistant lecturer; Phone Number: mobile 01093199561; Email: fatma.hassanain@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 25 - 65 years.
2. Diagnosed with mild, moderate to severe OSA based American Acadmey of Sleep Medicine (AASM) severity Index of apnea hypopnea index (AHI) after Polysomnography (AHI ≥ 5-15 mild, ≥15-30 moderate, ≥30 severe) based on a prior sleep study.
3. BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
4. Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.

Exclusion Criteria:

1. Subjects with a high percentage of central apneas suggesting heart failure.
2. Contraindication to general anesthesia or surgery.
3. Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
4. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction).
5. Tonsil size ≥ +3.
6. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate or tonsils).
7. Oral cancer or non-healing oral wounds.
8. Presence of symptoms of influenza-like symptoms.
9. History of surgery affecting the tongue [transoral robotic surgery (TORS), semi-glossectomy, radio-frequency ablation of base of tongue (RFBOT), maxillomandibular advancement (MMA), hypoglossal nerve stimulation (HGNS)].
10. History of radiation therapy to neck or upper respiratory tract
11. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).
12. Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
13. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
14. Currently receiving treatment for severe cardiac valvular dysfunction, new york heart association (NYHA) Class III or IV heart failure, unstable angina or recent (< 12 month) myocardial infarction or severe cardiac arrhythmias.
15. Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months.
16. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 12 months.
17. History or current clinical evidence of transient ischaemic attack (TIA) or stroke or muscular dysfunction.
18. Taking medications that in the opinion of the consulting physician may alter consciousness, the pattern of respiration, or sleep architecture, such examples being benzodiazepines, opiates, neuroleptics, prescription stimulants, phenothiazine, or any form of chemical substance abuse.
19. History of dementia or active psychiatric disease that may impact study compliance.
20. Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date).
21. Unable and/or unwilling to comply with study requirements or to provide written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: evaluation of cryotherapy as treatment for obstructive sleep apnea patients	Procedure: cryotherapy; Cryotherapy at sites of vibration as origin of snoring and site of collapse for patients with obstructive sleep apnea syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
value, side effect and impact of cryotherapy in treatment of patients with obstructive sleep apnea syndrome	we use drug induced sleep endoscopy during intervention and use polysomnography before the intervention as diagnostic for cases and after intervention for follow up of cases	polysomnography will done after 2 weeks of intervention

Collaborators and Investigators

• Sponsor: Sohag University
• Collaborators: Mansoura University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: Soh-Med-21-12-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No