Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction

NCT05582070 | Completed

• 1 other identifier: CHUBX 2022/15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Obstructive Sleep Apnea; Nasal Obstruction

Keywords

OSA; sleep apnea; nasal surgery; nasal desobstruction; sleep quality; actigraphy; wake after sleep onset; WASO

Outcome Measures

Primary Outcomes (1)

• Wake after sleep onset

  Wake after sleep onset in minutes

  6 months after inclusion (M0)

Secondary Outcomes (9)

• Total Sleep time

  Change from baseline (M0) and 4 month after surgery (M6)

• Time in bed

  Change from baseline (M0) and 4 month after surgery (M6)

• Sleep latency

  Change from baseline (M0) and 4 month after surgery (M6)

• Sleep efficiency

  Change from baseline (M0) and 4 month after surgery (M6)

• Pittsburgh Sleep Quality Index

  Change from baseline (M0) and 4 month after surgery (M6)

Study Arms (1)

actigraphy

EXPERIMENTAL

Patient with nasal obstruction

Other: actigraphy

Interventions

actigraphy OTHER

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.

actigraphy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Nasal Obstruction; Sleep Initiation and Maintenance Disorders

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, monocentric study, non-controlled study

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Study Start: September 6, 2022
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)