New Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome

NCT05206916 | Unknown

• 1 other identifier: Soh-Med-21-12-22
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

evaluation of cryotherapy as treatment for obstructive sleep apnea patients

OTHER

Procedure: cryotherapy

Interventions

cryotherapy PROCEDURE

Cryotherapy at sites of vibration as origin of snoring and site of collapse for patients with obstructive sleep apnea syndrome

evaluation of cryotherapy as treatment for obstructive sleep apnea patients

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25 - 65 years.
• 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.
• BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
• Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.

You may not qualify if:

• Subjects with a high percentage of central apneas suggesting heart failure.
• Contraindication to general anesthesia or surgery.
• Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
• Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction).
• Tonsil size ≥ +3.
• Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate or tonsils).
• Oral cancer or non-healing oral wounds.
• Presence of symptoms of influenza-like symptoms.
• History of surgery affecting the tongue \[transoral robotic surgery (TORS), semi-glossectomy, radio-frequency ablation of base of tongue (RFBOT), maxillomandibular advancement (MMA), hypoglossal nerve stimulation (HGNS)\].
• History of radiation therapy to neck or upper respiratory tract
• Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).
• Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
• Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
• 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.
• Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months.

Sponsors & Collaborators

• Sohag University: lead
• Mansoura University: collaborator

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

fatma h mohamed, assistant lecturer

CONTACT

01093199561; fatma.hassanain@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistent lecturer of chest diseases and tuberculosis

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 25, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share