Clinical trial NCT02027142: Sleep Quality, Daytime Sleepiness and Insomnia in Patients With Endometriosis: a Case-control Study.
Official title: Symptomatic Endometriosis of the Posterior Cul-de-sac is Associated With Impaired Sleep Quality, Excessive Daytime Sleepiness and Insomnia: a Case-control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Sleep
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 290
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study were recruited women referred to two academic centres for the diagnosis and treatment of endometriosis (cases) and women referred to our Institutions because of routine gynaecologic consultations (controls).

Brief summary: This study included women referred to two academic centres for the diagnosis and treatment of endometriosis (cases) and women referred to our Institutions because of routine gynaecologic consultations (controls). In this age-matched case-control study, the aimdy was to assess quality of sleep, the average daytime sleepiness and insomnia in patients with endometriosis by using three different self-reported questionnaires.


Eligibility criteria: Inclusion Criteria:

Reproductive age Surgical and histological diagnosis of rectovaginal endometriosis

Exclusion Criteria:

Suspicion of endometriosis (based on evaluation of symptoms, gynaecological examination and transvaginal ultrasonography) History of infertility Previous diagnosis of endometriosis Gynaecological, intestinal and urological diseases causing abdominal pain (e.g. pelvic congestion syndrome, bladder pain syndrome) Severe underlying comorbidities (cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological, or psychiatric) Pregnancy at any gestational age Suspicion or diagnosis of oncological pathology Use of gonadotropin releasing hormone analogues (GnRH-a) Restless legs syndrome Shift work Use of antiallergic drugs Narcotics Refusal or inability to sign the informed consent form or complete the study questionnaires

Primary outcomes:
measure: Quality of sleep.
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of being scheduled for surgery (3-4 months before the operation). Controls were administered and fulfilled the questionnaires after routine gynaecologic consultation.
Secondary outcomes:
measure: Average daytime sleepiness.
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of being scheduled for surgery (3-4 months before the operation). Controls were administered and fulfilled the questionnaires after routine gynaecologic consultation.
measure: Insomnia.
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of being scheduled for surgery (3-4 months before the operation). Controls were administered and fulfilled the questionnaires after routine gynaecologic consultation.
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
state: Ligury
city: Milan
country: Italy
facility: IRRCS San Raffaele Hospital and Vita-Salute San Raffaele University
state: Lombardy
Study officials:
affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: Umberto Leone Roberti Maggiore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: Simone Ferrero, PhD
role: STUDY_DIRECTOR
affiliation: IRRCS San Raffaele Hospital and Vita-Salute San Raffaele University of Milan
name: Stefano Salvatore, MD
role: PRINCIPAL_INVESTIGATOR
References: