NCT02027142

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 290 (actual)
• Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometriosis
• Sleep

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2014-01-03
• Last updated: 2017-05-04

Locations

2 sites across 1 country: Italy