Clinical trial NCT05582070: Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
Official title: Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Obstructive Sleep Apnea
Nasal Obstruction
Keywords: OSA
sleep apnea
nasal surgery
nasal desobstruction
sleep quality
actigraphy
wake after sleep onset
WASO
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, monocentric study, non-controlled study
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Obstructive sleep apnea syndrome (OSA) is a sleep breathing disorder characterised by episodes of complete or partial obstruction of the upper airway. OSA is a common disease which impacts quality of life, mood, cardiovascular morbidity, and mortality. It is often under-diagnosed and is estimated to affect at least 2-5% of the female population and 3-7% of the male population.

Currently, nasal obstruction is not recognised as an independent risk factor for obstructive sleep apnea syndrome. The current definition of OSA is based on an Apnea/Hypopnea index (AHI) greater than five. However, most studies do not find a decrease in this index after nasal desobstruction surgery despite a significant improvement in sleep quality scales. The AHI index appears to be a limited paraclinical criteria to assess the impact of nasal obstruction on sleep quality.

Other objective paraclinical criteria have been used in other nosological sleep settings to objectively assess sleep quality. These include the WASO (wake after sleep onset) criteria. To investigators knowledge, no study has assessed this parameter before and after a nasal desobstruction surgery.

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 objective paraclinical criteria WASO, in patients presenting with sleep disorders and severe nasal obstruction.

Eligibility criteria: 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 and to answer in French
* impossibility to participate in the entire study
* no coverage by Social security

Primary outcomes:
measure: Wake after sleep onset
timeFrame: 6 months after inclusion (M0)
Secondary outcomes:
measure: Total Sleep time
timeFrame: Change from baseline (M0) and 4 month after surgery (M6)
measure: Time in bed
timeFrame: Change from baseline (M0) and 4 month after surgery (M6)
measure: Sleep latency
timeFrame: Change from baseline (M0) and 4 month after surgery (M6)
measure: Sleep efficiency
timeFrame: Change from baseline (M0) and 4 month after surgery (M6)
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from baseline (M0) and 4 month after surgery (M6)
measure: Pichot Qualitative Fatigue Scale score
timeFrame: Change from baseline (M0) and 4 month after surgery (M6)
measure: Epworth Sleepiness Scale (ESS) score
timeFrame: Change from baseline (M0) and 4 month after surgery (M6)
measure: Insomnia Severity Index
timeFrame: Change from baseline (M0) and 4 month after surgery (M6)
measure: Nasal obstruction scale
timeFrame: Change from baseline (M0) and 4 month after surgery (M6)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: