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

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

Study Overview

• Status: Completed
• Conditions: Sleep; Endometriosis
• Intervention / Treatment: Other: Pittsburgh Sleep Quality Index.; Other: Epworth sleepiness scale.; Other: Insomnia Severity Index.; Other: The Endometriosis Health Profile.

• Study Type: Observational
• Enrollment (Actual): 290

Contacts and Locations

Study Locations

• Italy
  • Ligury
    • Genoa, Ligury, Italy, 16122
      • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • IRRCS San Raffaele Hospital and Vita-Salute San Raffaele University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Women referred to two academic centres for the diagnosis and treatment of endometriosis.	Other: Pittsburgh Sleep Quality Index.; 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.; Other: Epworth sleepiness scale.; Epworth sleepiness scale is an 8-item questionnaire developed to measure average daytime sleepiness. A total score ≥ 10 indicates excessive daytime sleepiness.; Other: Insomnia Severity Index.; 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).; Other: The Endometriosis Health Profile.; 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).
Controls; Women referred to our Institutions because of routine gynaecologic consultations.	Other: Pittsburgh Sleep Quality Index.; 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.; Other: Epworth sleepiness scale.; Epworth sleepiness scale is an 8-item questionnaire developed to measure average daytime sleepiness. A total score ≥ 10 indicates excessive daytime sleepiness.; Other: Insomnia Severity Index.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of sleep.	Quality of sleep was assessed by using the Pittsburgh Sleep Quality Index.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daytime sleepiness.	Average daytime sleepiness was assessed by using the Epworth sleepiness scale.	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.	Insomnia was assessed by using the Insomnia Severity Index.	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.

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Investigators: Principal Investigator: Stefano Salvatore, MD, IRRCS San Raffaele Hospital and Vita-Salute San Raffaele University of Milan

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 2, 2014
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endometriosis; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: Sleep and endometriosis.