Predictive Value of Induced Sleep Endoscopy on Surgical Indication in Obstructive Sleep Apnea Syndromes

Obstructive Sleep Apnea Syndrome Clinical Trial

— SOMMEIL_INDUIT  

Official title:

Predictive Value of Induced Sleep Endoscopy on Surgical Indication in Obstructive Sleep Apnea Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201222
• Other study ID #: SOMMEIL_INDUIT
• Status: Completed
• Start date: December 15, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2022
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obstructive sleep apnea syndrome (OSA) is a pathology that affects 2 to 15% of the French adult population and more than 30% of subjects over 65 years old. It consists of repeated collapses of the upper airways during sleep leading to interruptions in ventilation (apneas) or significant reductions in ventilation (hypopneas). Balagny et al. have demonstrated the occurrence of hypertension in patients screened positive for sleep apnea syndrome in a French general population cohort. It is also established that sleep apnea increases the risk of cardiovascular disorders, such as metabolic syndrome (combining abdominal obesity and metabolic disorders), hypertension, heart rhythm disorders, especially at night, atherosclerosis (deposits of atheromatous plaques on the artery walls) or type 2 diabetes. These different complications increase the risk of cardiovascular accidents such as cardiac arrest, myocardial infarction, stroke, and expose to a risk of premature death (Inserm). The treatment of choice is night-time positive pressure ventilation, made possible by the use of a breathing apparatus (Continuous Positive Airway Pressure or CPAP). Alternatives to CPAP are the use of a nocturnal Mandibular Advancement Orthosis (MAO) which advances the jaw and allows a pharyngeal opening, and surgery in selected patients. The phenomenon at the origin of apneas is due to a relaxation of the muscles of the pharyngeal wall located at different heights. This obstruction is favored by anatomical particularities specific to each individual. The clinical examination can detect certain anomalies (enlarged tonsils, obstructive soft palate, prominent tongue base, abnormal epiglottis) and propose surgery to remove the obstruction.

Nevertheless, it remains difficult to affirm that the detected anomaly is really at the origin of the obstruction and surgical failures are frequent. Endoscopy under induced sleep has been developed for about 10 years in France. This examination, widely used in the world, remains confidential in France. It consists, in the operating room, in inducing a medicated sleep (specific drugs delivered by an anesthetist) and performing a pharyngolaryngeal fibroscopy. The ENT physician can then visualize "live" the site and origin of the obstruction during an apnea.

The main objective is to evaluate the interest of endoscopy under sleep before making a surgical indication in a patient presenting a sleep apnea syndrome. The secondary objective is to evaluate the reliability of sleep endoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: October 31, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient whose age = 18 years

• Patient with sleep apnea syndrome confirmed by polysomnographic or polygraphic recording The parameters of interest (Apnea Hypopnea Index, percentage of snoring and desaturation during the recording) are collected and in an identical way by its two examinations. They differ by the recording of other parameters.

• Patient for whom a sleep endoscopy is performed: clinical/recording discordance, failure or intolerance of the proposed treatment (OAM, PPC); surgical indication for OSA (tonsillectomy and/or velopasty)

• French speaking patient

Exclusion Criteria:

• Patient under guardianship or curatorship

• Patient deprived of liberty

• Patient under court protection

• Patient objecting to the use of his data for this research

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Locations

Country	Name	City	State
France	Institut Arthur Vernes	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph	Institut Arthur Vernes

Country where clinical trial is conducted

France, 

References & Publications (5)

Aljassim A, Pang KP, Rotenberg BW. Does Drug-Induced Sleep Endoscopy Improve Sleep Surgery Outcomes? Laryngoscope. 2020 Nov;130(11):2518-2519. doi: 10.1002/lary.28668. Epub 2020 Apr 18. Review. — View Citation

Chong KB, De Vito A, Vicini C. Drug-Induced Sleep Endoscopy in Treatment Options Selection. Sleep Med Clin. 2019 Mar;14(1):33-40. doi: 10.1016/j.jsmc.2018.11.001. Epub 2018 Dec 3. Review. — View Citation

De Vito A, Carrasco Llatas M, Ravesloot MJ, Kotecha B, De Vries N, Hamans E, Maurer J, Bosi M, Blumen M, Heiser C, Herzog M, Montevecchi F, Corso RM, Braghiroli A, Gobbi R, Vroegop A, Vonk PE, Hohenhorst W, Piccin O, Sorrenti G, Vanderveken OM, Vicini C. European position paper on drug-induced sleep endoscopy: 2017 Update. Clin Otolaryngol. 2018 Dec;43(6):1541-1552. doi: 10.1111/coa.13213. Epub 2018 Sep 30. Review. — View Citation

Kezirian EJ, Hohenhorst W, de Vries N. Drug-induced sleep endoscopy: the VOTE classification. Eur Arch Otorhinolaryngol. 2011 Aug;268(8):1233-1236. doi: 10.1007/s00405-011-1633-8. Epub 2011 May 26. — View Citation

Kotecha B, De Vito A. Drug induced sleep endoscopy: its role in evaluation of the upper airway obstruction and patient selection for surgical and non-surgical treatment. J Thorac Dis. 2018 Jan;10(Suppl 1):S40-S47. doi: 10.21037/jtd.2017.10.32. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interest of sleep endoscopy before making a surgical indication in a patient with sleep apnea syndrome	This outcome corresponds to the number of patients for whom the surgical indication was maintained according to the data collected during the sleep endoscopy.	Day 1
Secondary	Reliability of endoscopy under sleep	This outcome corresponds to the comparison of the number of patients for whom the treatment considered before the sleep endoscopy and the type of treatment were finally performed.	Day 1

External Links

•   Prévalence du syndrome d'apnée du sommeil et son association avec les évènements cardiovasculaires dans la population générale française