Polysomnographic Findings in Nasal Polyposis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopic sinus surgery
Procedure/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
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: endoscopic sinus surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Slow-wave sleep duration
Slow-wave sleep duration is measured one month before surgery and 3 months after surgery
Time frame
1 month before surgery and 3 months postoperativelySecondary outcomes
1
change in total sleep duration
duration in min of total sleep at each endpoint
Time frame
At 1 month before surgery and at 3 months postoperatively2
Change in the number of brief wakefulness
comparison of the number of wakefulness between visits
Time frame
At 1 month before surgery and at 3 months postoperatively3
change in Apnea-hypopnea index
This index measures the number of apnea and hypopnea during the total sleep duration.
Time frame
At 1 month before surgery and at 3 months postoperatively4
Change in time with oxygen desaturation below 90%
desaturation before anf after surgery measured
Time frame
At 1 month before surgery and at 3 months postoperativelySponsors and contacts
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Source ClinicalTrials.gov