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

Primary Purpose

Sleep Apnea, Obstructive Sleep Apnea, Nasal Obstruction

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

actigraphy

About this trial

This is an interventional basic science trial for Sleep Apnea focused on measuring OSA, sleep apnea, nasal surgery, nasal desobstruction, sleep quality, actigraphy, wake after sleep onset, WASO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de BordeauxRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

actigraphy

Arm Description

Patient with nasal obstruction

Outcomes

Primary Outcome Measures

Wake after sleep onset

Wake after sleep onset in minutes

Secondary Outcome Measures

Total Sleep time

Total sleep time in minutes

Time in bed

Time in bed in minutes

Sleep latency

Duration of time in minutes from turning the light off to falling asleep

Sleep efficiency

ratio of total sleep time to time in bed

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)

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

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'.

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).

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.

Full Information

NCT ID

NCT05582070

First Posted

October 12, 2022

Last Updated

October 12, 2022

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT05582070

Brief Title

Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction

Acronym

SOMNOSE

Official Title

Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 6, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Obstructive Sleep Apnea, Nasal Obstruction

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

prospective, monocentric study, non-controlled study

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

actigraphy

Arm Type

Experimental

Arm Description

Patient with nasal obstruction

Intervention Type

Other

Intervention Name(s)

actigraphy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Wake after sleep onset

Description

Wake after sleep onset in minutes

Time Frame

6 months after inclusion (M0)

Secondary Outcome Measure Information:

Title

Total Sleep time

Description

Total sleep time in minutes

Time Frame