CHU de Bordeaux
Bordeaux, France
NCT Number: NCT05582070
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bordeaux, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Actigraphy examination will be performed during 2 periods of 7 days before and after nose nasal desobstruction surgery (septoplasty, septorhinoplasty or total ethmoidectomy). Respectively 2 months before surgery (inclusion) and 4 months after surgery.
Time frame: 6 months after inclusion (M0)
Wake after sleep onset in minutes
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Total sleep time in minutes
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Time in bed in minutes
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Duration of time in minutes from turning the light off to falling asleep
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
ratio of total sleep time to time in bed
Time frame: 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)
Time frame: 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 fatigue
Time frame: 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'.
Time frame: 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).
Time frame: 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.
University Hospital, Bordeaux
Other
Acronym: SOMNOSE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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