EndometriosisNCT02027142
Sleep Quality, Daytime Sleepiness and Insomnia in Patients With Endometriosis: a Case-control Study.
An observational study of Endometriosis and Sleep, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 2 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Sleep
- What is being tested?
- Pittsburgh Sleep Quality Index., Epworth sleepiness scale. and Insomnia Severity Index.
- How many people
- 290 participants
- Where
- 2 sitesItaly
- Study dates
- May 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- Reproductive age Surgical and histological diagnosis of rectovaginal endometriosis
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
Genoa, Ligury, 16122
IRRCS San Raffaele Hospital and Vita-Salute San Raffaele University
Milan, Lombardy, 20132
About this 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.
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
- Being tested
- Pittsburgh Sleep Quality Index., Epworth sleepiness scale., Insomnia Severity Index., The Endometriosis Health Profile.
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Cases | Women referred to two academic centres for the diagnosis and treatment of endometriosis. Receives: Other: Pittsburgh Sleep Quality Index.; Other: Epworth sleepiness scale.; Other: Insomnia Severity Index.; Other: The Endometriosis Health Profile. | |
| Controls | Women referred to our Institutions because of routine gynaecologic consultations. Receives: Other: Pittsburgh Sleep Quality Index.; Other: Epworth sleepiness scale.; Other: Insomnia Severity Index. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sleep.
Quality of sleep was assessed by using the Pittsburgh Sleep Quality Index.
Measured: 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 (2)
Average daytime sleepiness.
Average daytime sleepiness was assessed by using the Epworth sleepiness scale.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umberto Leone Roberti Maggiore, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Investigators
- Umberto Leone Roberti Maggiore, MD, Principal investigator, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalySimone Ferrero, PhD, Study director, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyStefano Salvatore, MD, Principal investigator, IRRCS San Raffaele Hospital and Vita-Salute San Raffaele University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027142
- Sponsor's protocol ID
- Sleep and endometriosis.
- Status last verified
- May 2017
- First submitted
- 2 Jan 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02027142
- Acronym / sponsor ID
- Sleep and endometriosis.
- Conditions
- Endometriosis, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Pittsburgh Sleep Quality Index., Other: Epworth sleepiness scale., Other: Insomnia Severity Index., Other: The Endometriosis Health Profile.Women referred to two academic centres for the diagnosis and treatment of endometriosis. |
| Controls | – | Other: Pittsburgh Sleep Quality Index., Other: Epworth sleepiness scale., Other: Insomnia Severity Index.Women referred to our Institutions because of routine gynaecologic consultations. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (1 listed)
- Reproductive age Surgical and histological diagnosis of rectovaginal endometriosis
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cases, Controls |
| 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 | Cases, Controls |
| 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 | Cases, Controls |
| 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). | Other | Cases |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto Leone Roberti Maggiore, MD principal investigator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Simone Ferrero, PhD study director
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Stefano Salvatore, MD principal investigator
IRRCS San Raffaele Hospital and Vita-Salute San Raffaele University of Milan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Sleep, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.