Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
- Conditions
- Sleep ApneaObstructive Sleep ApneaNasal Obstruction
- Interventions
- Other: actigraphy
- Registration Number
- NCT05582070
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description actigraphy actigraphy Patient with nasal obstruction
- Primary Outcome Measures
Name Time Method Wake after sleep onset 6 months after inclusion (M0) Wake after sleep onset in minutes
- Secondary Outcome Measures
Name Time Method Time in bed Change from baseline (M0) and 4 month after surgery (M6) Time in bed in minutes
Sleep efficiency Change from baseline (M0) and 4 month after surgery (M6) ratio of total sleep time to time in bed
Pichot Qualitative Fatigue Scale score Change from baseline (M0) and 4 month after surgery (M6) the Fatigue os measured by Pichot Qualitative Fatigue Scale witch is a 8-items self-administered questionnaire asking about fatigue.
A 5-points scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 32.
A score above 22 means an excessive state of fatigueSleep latency Change from baseline (M0) and 4 month after surgery (M6) Duration of time in minutes from turning the light off to falling asleep
Pittsburgh Sleep Quality Index Change from baseline (M0) and 4 month after surgery (M6) Index from 0 (meaning that there are no difficulties) to 21 (indicating major difficulties) about quality of sleep (the lowest is the index the better is the quality of sleep)
Total Sleep time Change from baseline (M0) and 4 month after surgery (M6) Total sleep time in minutes
Epworth Sleepiness Scale (ESS) score Change from baseline (M0) and 4 month after surgery (M6) Sleepiness complaints with ESS questionnaire. The ESS score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.
Nasal obstruction scale Change from baseline (M0) and 4 month after surgery (M6) Nasal Respiratory complaints measured by Nasal Obstruction Symptom Evaluation (NOSE questionnaire) The NOSE Scale is a 5-items self-administered questionnaire asking nose obstruction.
A 5-points scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 20.Insomnia Severity Index Change from baseline (M0) and 4 month after surgery (M6) The Insomnia Severity Index is a 7-item self-administered questionnaire asking about difficulties sleeping and thoughts and worries about sleep.
A 5-point scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28.
The total score is interpreted as follows:
absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Trial Locations
- Locations (1)
CHU de Bordeaux
🇫🇷Bordeaux, France