Sleep ApneaSOMNOSENCT05582070
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
A study testing actigraphy in people with Sleep Apnea and Obstructive Sleep Apnea, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive Sleep Apnea, Nasal Obstruction
- What is being tested?
- actigraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2022to 21 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive Sleep Apnea, Nasal Obstruction
- Being tested
- actigraphy
- Keywords
- OSA, sleep apnea, nasal surgery, nasal desobstruction, sleep quality, actigraphy, wake after sleep onset, WASO
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Nasal Obstruction, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
actigraphyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| actigraphy | Experimental | Patient with nasal obstruction Receives: Other: actigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wake after sleep onset
Wake after sleep onset in minutes
Measured: 6 months after inclusion (M0)
Secondary outcomes (9)
Total Sleep time
Total sleep time in minutes
Measured: Change from baseline (M0) and 4 month after surgery (M6)
Time in bed
Time in bed in minutes
Measured: 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
Measured: Change from baseline (M0) and 4 month after surgery (M6)
Sleep efficiency
ratio of total sleep time to time in bed
Measured: 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)
Measured: 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
Measured: 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'.
Measured: 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).
Measured: 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.
Measured: Change from baseline (M0) and 4 month after surgery (M6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start6 Sep 2022
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, monocentric study, non-controlled study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582070
- Sponsor's protocol ID
- CHUBX 2022/15
- Acronym
- SOMNOSE
- Status last verified
- Feb 2024
- First submitted
- 12 Oct 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
- ClinicalTrials.gov ID
- NCT05582070
- Acronym / sponsor ID
- SOMNOSE / CHUBX 2022/15
- Conditions
- Sleep Apnea, Obstructive Sleep Apnea, Nasal Obstruction
- Keywords
- OSA, sleep apnea, nasal surgery, nasal desobstruction, sleep quality, actigraphy, wake after sleep onset, WASO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, monocentric study, non-controlled study
| Arm | Type | Receives |
|---|---|---|
| actigraphy | Experimental | Other: actigraphyPatient with nasal obstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| actigraphyActigraphy 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. | Other | actigraphy |
Primary outcome
Wake after sleep onset
Time frame: 6 months after inclusion (M0)
Wake after sleep onset in minutes
9 secondary outcomes
Total Sleep time
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Time in bed
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Sleep latency
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Sleep efficiency
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Pittsburgh Sleep Quality Index
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Pichot Qualitative Fatigue Scale score
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Epworth Sleepiness Scale (ESS) score
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Insomnia Severity Index
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Nasal obstruction scale
Time frame: Change from baseline (M0) and 4 month after surgery (M6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing actigraphy in people with Sleep Apnea and Obstructive Sleep Apnea, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wake after sleep onset (time frame: 6 months after inclusion (M0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.