Clinical trial NCT05206916: New Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome
Official title: Evaluation of Novel Drug Induced Sleep Endoscopy Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
Collaborators: name: Mansoura University
First posted: 2022-01-25
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: value, side effect and impact of cryotherapy in treatment of patients with obstructive sleep apnea syndrome
timeFrame: polysomnography will done after 2 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: