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NCT Number: NCT03725956

Polysomnographic Findings in Nasal Polyposis

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.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps Apnea Dyssomnias Nasal Polyps Nervous System Diseases Nose Diseases Obstructive Sleep Apnea Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Claude Huriez, CHU

Lille, France

Location status: Recruiting

Location contact

Geoffrey Mortuaire, MD

PRINCIPAL_INVESTIGATOR

About this study

the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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…)

Treatment and study plan

Endoscopic sinus surgery

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. change in total sleep duration

    Time frame: At 1 month before surgery and at 3 months postoperatively

    duration in min of total sleep at each endpoint

  2. Change in the number of brief wakefulness

    Time frame: At 1 month before surgery and at 3 months postoperatively

    comparison of the number of wakefulness between visits

  3. change in Apnea-hypopnea index

    Time frame: At 1 month before surgery and at 3 months postoperatively

    This index measures the number of apnea and hypopnea during the total sleep duration.

  4. Change in time with oxygen desaturation below 90%

    Time frame: At 1 month before surgery and at 3 months postoperatively

    desaturation before anf after surgery measured

  5. change in Epworth sleepiness scale scores

    Time frame: At 1 month before surgery and at 3 months postoperatively

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Geoffrey Mortuaire, MD

CONTACT

[email protected]

03 20 44 56 72 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Effects of Endoscopic Sinus Surgery on Sleep Disorder in Patients With Chronic Rhinosinusitis With Polyps

Acronym: POLYSOMNO

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Oct 31, 2018
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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