Chronic Rhinosinusitis With Nasal PolypsPOLYSOMNONCT03725956
Polysomnographic Findings in Nasal Polyposis
A study testing Endoscopic sinus surgery in people with Chronic Rhinosinusitis With Nasal Polyps and Obstructive Sleep Apnea, run by University Hospital, Lille at 1 site in France.
Trial summary
Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps, Obstructive Sleep Apnea
- What is being tested?
- Endoscopic sinus surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients who underwent endoscopic sinus surgery for recalcitrant nasal polyposis (failure of a 4-month corticosteroid medical treatment) Social insured patient
- Patient willing to comply with all procedures of the study and its duration
- Patient giving consent
Who cannot join
- Patients with previous nasal surgery for nasal polyposis
- Patients with previous continuous positive airway pressure therapy for obstructive sleep apnea
- Non-coverage by the social security scheme
- Patient unable to receive informed information
- Refusal to sign the consent
- Person deprived of the liberty
- Person benefiting from a system of legal protection (guardianship…)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Claude Huriez, CHU
Lille
Geoffrey Mortuaire, MD
About this study
Official title: Effects of Endoscopic Sinus Surgery on Sleep Disorder in Patients With Chronic Rhinosinusitis With Polyps
Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.
Read the detailed description
the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.
- Being tested
- Endoscopic sinus surgery
- Keywords
- Nasal polyposis, sleep, sinus surgery, polysomnography, quality of life
- Medical subject headings
- Sleep Apnea, Obstructive, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sinus surgeryProcedure or surgery
Surgical procedure under general anaesthesia:
Consists of the removal of bone boundaries between sinus cavities (ethmoidectomy) with nasal polyps resection in order to retrieve nasal patency and sinus drainage Polysomnographic assessment as routinely applied in clinical practice
| Study group | Role | What they receive |
|---|---|---|
| endoscopic sinus surgery | Experimental | Single group of patients with nasal polyposis eligible for endoscopic sinus surgery Receives: Procedure: Endoscopic sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Slow-wave sleep duration
Slow-wave sleep duration is measured one month before surgery and 3 months after surgery
Measured: 1 month before surgery and 3 months postoperatively
Secondary outcomes (5)
change in total sleep duration
duration in min of total sleep at each endpoint
Measured: At 1 month before surgery and at 3 months postoperatively
Change in the number of brief wakefulness
comparison of the number of wakefulness between visits
Measured: At 1 month before surgery and at 3 months postoperatively
change in Apnea-hypopnea index
This index measures the number of apnea and hypopnea during the total sleep duration.
Measured: At 1 month before surgery and at 3 months postoperatively
Change in time with oxygen desaturation below 90%
desaturation before anf after surgery measured
Measured: At 1 month before surgery and at 3 months postoperatively
change in Epworth sleepiness scale scores
The Epworth sleepiness scale score is a questionnaire based of 8 questions assessing daytime sleepiness. Each question is graded from 0 to 3. A total score ranging from 0 to 24 is established:
1 to 6 points: Normal sleep 7 to 8 points: Average sleepiness 9 to 24 points: Abnormal (possibly pathologic) sleepiness
Measured: At 1 month before surgery and at 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start17 Jan 2019
- Primary completion1 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey Mortuaire, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725956
- Sponsor's protocol ID
- 2018_19
- Other IDs
- 2018-A01650-55
- Acronym
- POLYSOMNO
- Status last verified
- Apr 2026
- First submitted
- 18 Oct 2018
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endoscopic Sinus Surgery on Sleep Disorder in Patients With Chronic Rhinosinusitis With Polyps
- ClinicalTrials.gov ID
- NCT03725956
- Acronym / sponsor ID
- POLYSOMNO / 2018_19
- Keywords
- Nasal polyposis, sleep, sinus surgery, polysomnography, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Oct 2018 (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.
Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.
Detailed description
the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopic sinus surgery | Experimental | Procedure: Endoscopic sinus surgerySingle group of patients with nasal polyposis eligible for endoscopic sinus surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who underwent endoscopic sinus surgery for recalcitrant nasal polyposis (failure of a 4-month corticosteroid medical treatment) Social insured patient
- Patient willing to comply with all procedures of the study and its duration
- Patient giving consent
Key exclusion criteria (7 listed)
- Patients with previous nasal surgery for nasal polyposis
- Patients with previous continuous positive airway pressure therapy for obstructive sleep apnea
- Non-coverage by the social security scheme
- Patient unable to receive informed information
- Refusal to sign the consent
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 |
|---|---|---|
| Endoscopic sinus surgerySurgical procedure under general anaesthesia: Consists of the removal of bone boundaries between sinus cavities (ethmoidectomy) with nasal polyps resection in order to retrieve nasal patency and sinus drainage Polysomnographic assessment as routinely applied in clinical practice | Procedure or surgery | endoscopic sinus surgery |
Primary outcome
Change in Slow-wave sleep duration
Time frame: 1 month before surgery and 3 months postoperatively
Slow-wave sleep duration is measured one month before surgery and 3 months after surgery
5 secondary outcomes
change in total sleep duration
Time frame: At 1 month before surgery and at 3 months postoperatively
Change in the number of brief wakefulness
Time frame: At 1 month before surgery and at 3 months postoperatively
change in Apnea-hypopnea index
Time frame: At 1 month before surgery and at 3 months postoperatively
Change in time with oxygen desaturation below 90%
Time frame: At 1 month before surgery and at 3 months postoperatively
change in Epworth sleepiness scale scores
Time frame: At 1 month before surgery and at 3 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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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.
Geoffrey Mortuaire, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic sinus surgery in people with Chronic Rhinosinusitis With Nasal Polyps and Obstructive Sleep Apnea, run by University Hospital, Lille 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geoffrey Mortuaire, MD (03 20 44 56 72 ext. +33, geoffrey.mortuaire@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Slow-wave sleep duration (time frame: 1 month before surgery and 3 months postoperatively). 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 6 May 2026.