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Completed

NCT Number: NCT02027142

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Sleep Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pittsburgh Sleep Quality Index.

Other

Pittsburgh Sleep Quality Index is an effective instrument used to measure the quality and patterns of sleep of patients. It allows evaluating "poor" from "good" sleep by assessing seven domains. A total score ≤ 5 indicated good sleep quality while a total score > 5 was indicated poor sleep quality.

Epworth sleepiness scale.

Other

Epworth sleepiness scale is an 8-item questionnaire developed to measure average daytime sleepiness. A total score ≥ 10 indicates excessive daytime sleepiness.

Insomnia Severity Index.

Other

Insomnia Severity Index is a 7-item questionnaire developed to measure insomnia. A total score between 0 and 7 correspond to not clinically significant insomnia, between 8 and 14 to subthreshold insomnia, between 15 and 21 to clinical insomnia (moderate), between 22 and 28 to clinical insomnia (severe).

The Endometriosis Health Profile.

Other

The Endometriosis Health Profile is a patient generated instrument that evaluates disease-specific health-related quality of life in patients with endometriosis. The questionnaire is administrable to all patients with endometriosis and it consists in 30 items divided in 5 domains (pain, control and powerlessness, emotional well-being, social support and self-image). Each scale for each domain is comprised between 0 (indicating the best health status) and 100 (indicating the worst health status).

Primary outcomes

  1. Quality of sleep.

    Time frame: 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.

    Quality of sleep was assessed by using the Pittsburgh Sleep Quality Index.

Secondary outcomes

  1. Average daytime sleepiness.

    Time frame: 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.

    Average daytime sleepiness was assessed by using the Epworth sleepiness scale.

  2. Insomnia.

    Time frame: 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.

    Insomnia was assessed by using the Insomnia Severity Index.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Symptomatic Endometriosis of the Posterior Cul-de-sac is Associated With Impaired Sleep Quality, Excessive Daytime Sleepiness and Insomnia: a Case-control Study.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 3, 2014
Registry last updated
May 4, 2017

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

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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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