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Sleep Quality, Daytime Sleepiness and Insomnia in Patients With Endometriosis: a Case-control Study.

I

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Status

Completed

Conditions

Endometriosis
Sleep

Treatments

Other: The Endometriosis Health Profile.
Other: Insomnia Severity Index.
Other: Pittsburgh Sleep Quality Index.
Other: Epworth sleepiness scale.

Study type

Observational

Funder types

Other

Identifiers

NCT02027142
Sleep and endometriosis.

Details and patient eligibility

About

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.

Enrollment

290 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

290 participants in 2 patient groups

Cases
Description:
Women referred to two academic centres for the diagnosis and treatment of endometriosis.
Treatment:
Other: Insomnia Severity Index.
Other: Pittsburgh Sleep Quality Index.
Other: Epworth sleepiness scale.
Other: The Endometriosis Health Profile.
Controls
Description:
Women referred to our Institutions because of routine gynaecologic consultations.
Treatment:
Other: Insomnia Severity Index.
Other: Pittsburgh Sleep Quality Index.
Other: Epworth sleepiness scale.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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