Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction (NCT05582070) | Clinical Trial Compass
CompletedNot Applicable
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
France20 participantsStarted 2022-09-06
Plain-language summary
The aim of the study is to evaluate the effect of nasal desobstruction surgery (septoplasty, septorhinoplasty or total ethmoidectomy) on sleep quality, assessed by the variation of the Wake after sleep onset (WASO), in patients presenting with sleep disorders and severe nasal obstruction.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with chronic severe nasal obstruction of inflammatory (PNS) and/or morphological (symptomatic septal deviation) requiring surgical management
* NOSE \> 9/20
* BMI \< 30 kg/m2
* Over 18 years of age
* Pittsburgh Sleep Quality Index (PSQI) greater than or equal to 5
Exclusion Criteria:
* Patients with other sleep or wakefulness disorders: central sleep apnea syndromes, central hypersomnias including narcolepsy, parasomnia, restless legs syndrome and periodic leg movements.
* Craniofacial developmental abnormalities that may be responsible for OSA (retrognathia, endognathia, micro-mandibula, ogival palate, other occlusive disorder)
* Other identifiable obstructive site of the upper airways: tonsillar hypertrophy grade 3 and 4, macroglossia, unoperated vegetation hypertrophy, Mallampati score III or IV.
* Suspicion of anxiety or depressive disorder on the Hospital Anxiety and Depression scale (HAD) screening scale with H\>10 and/or A\>10.
* Use of psychotropic drugs or other respiratory depressant substances (morphine, chronic alcohol use, etc.)
* Night worker
* Other chronic rhinitis and rhinosinusitis
* Uncontrolled allergies
* Uncontrolled chronic respiratory disease
* Pregnancy
* Breastfeeding
* Subjects referred to in articles L.1121-5 to L.1121-8 and L.1122-1-2 of the public health code (e.g.: protected adults, people in emergency situations, people unable to give their personal consent etc...)
* Impossibility to understand the instructions …