Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction (SOMNOSE)

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Sleep Apnea; Nasal Obstruction
• Intervention / Treatment: Other: actigraphy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: actigraphy; Patient with nasal obstruction	Other: actigraphy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wake after sleep onset	Wake after sleep onset in minutes	6 months after inclusion (M0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep time	Total sleep time in minutes	Change from baseline (M0) and 4 month after surgery (M6)
Time in bed	Time in bed in minutes	Change from baseline (M0) and 4 month after surgery (M6)
Sleep latency	Duration of time in minutes from turning the light off to falling asleep	Change from baseline (M0) and 4 month after surgery (M6)
Sleep efficiency	ratio of total sleep time to time in bed	Change from baseline (M0) and 4 month after surgery (M6)
Pittsburgh Sleep Quality Index	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)	Change from baseline (M0) and 4 month after surgery (M6)
Pichot Qualitative Fatigue Scale score	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	Change from baseline (M0) and 4 month after surgery (M6)
Epworth Sleepiness Scale (ESS) score	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'.	Change from baseline (M0) and 4 month after surgery (M6)
Insomnia Severity Index	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).	Change from baseline (M0) and 4 month after surgery (M6)
Nasal obstruction scale	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.	Change from baseline (M0) and 4 month after surgery (M6)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): August 21, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: OSA; sleep apnea; sleep quality; actigraphy; wake after sleep onset; nasal surgery; nasal desobstruction; WASO
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Nasal Obstruction
• Other Study ID Numbers: CHUBX 2022/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No