Respiratory Disorder in Patient With Gestational DiabetesNCT02756442
Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese
A study testing Respiratory disorder assessment during sleep in people with Respiratory Disorder in Patient With Gestational Diabetes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Introduction: The pregnancy brings about physiological and hormonal modifications which cause sleep disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the pregnancy. Also a limited breathing airflow happens very often during the pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Respiratory Disorder in Patient With Gestational Diabetes
- What is being tested?
- Respiratory disorder assessment during sleep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Apr 2019
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant woman in the 3rd quarter of pregnancy (24 to 32 weeks amennorhea).
- Presenting a gestational diabetes ou not (=controle group)
- Written and signed consent.
Who cannot join
- Twin pregnancy
- High blood pressure before pregnancy
- Diabetes diagnosed before pregnancy
- Left ventricular ejection fraction below 40%
- Alcohol consumption (more than 7 glaces/day), drugs of type hypnotic, sedative, opioids
- History of gestational diabetes or glucose intolerance
- Severe cronical respiratory impairment (severe asthma)
- Creatinine clairance below 60 mL/min
Trial locations and contacts
1 site in 1 country.
About this study
Introduction:
The pregnancy brings about physiological and hormonal modifications which cause sleep disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the pregnancy. Also a limited breathing airflow happens very often during the pregnancy. The limited airflow causes micro-awakenings that enter in the frame of the high resistances airways syndrome. To our knowledge there is no study about the outcome of micro-awakenings at pregnant women.
Read more
Objectives:
To compare the prevalence of the high resistances airways syndrome (RERA) in pregnant woman with or without gestational diabetes
Methods :
It is a monocentrical prospective study at pregnant women after the 30th amenorrhea week who consul the gynecologie and obstetrics department of the CHU NORD in Marseille. We are going to compare the breathing disorder during sleep of a control group with a group of women with gestational diabetes. A polysomnograph will be run at the included patients' home.
Expected results :
The physiological and hormonal modifications during the pregnancy could favor nocturnal sleep events (snoring, SAHOS and RERA) and its complications as gravidic HPN And gestational diabetes cause maternal and fœtal and morbidity and mortality. We put the hypothesis that limited airflow in association with micro-awakenings in the RERA have a negative impact on the glucose metabolism and favor the gestational diabetes.
- Being tested
- Respiratory disorder assessment during sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory disorder assessment during sleepOther
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with gestational diabetes | Experimental | Not described Receives: Other: Respiratory disorder assessment during sleep |
| pregnant women without gestational diabetes | Active comparator | Not described Receives: Other: Respiratory disorder assessment during sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Disturbance Index
Compare the respiratory disorder during sleep for pregnant women betwwen 2 groups with and without gestational diabetes based on RDI (Respiratory Disturbance Index)
Measured: 4 month
Secondary outcomes (1)
Air flow debit associated to micro awaking during sleep
To assess the resistance airways syndrome
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Disorder in Patient With Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756442
- Sponsor's protocol ID
- 2015-A01796-43
- Other IDs
- 2015-41
- Status last verified
- Apr 2016
- First submitted
- 27 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese
- ClinicalTrials.gov ID
- NCT02756442
- Acronym / sponsor ID
- 2015-A01796-43
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 29 Apr 2016 (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.
Introduction:
The pregnancy brings about physiological and hormonal modifications which cause sleep disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the pregnancy. Also a limited breathing airflow happens very often during the pregnancy. The limited airflow causes micro-awakenings that enter in the frame of the high resistances airways syndrome. To our knowledge there is no study about the outcome of micro-awakenings at pregnant women.
Objectives:
To compare the prevalence of the high resistances airways syndrome (RERA) in pregnant woman with or without gestational diabetes
Methods :
It is a monocentrical prospective study at pregnant women after the 30th amenorrhea week who consul the gynecologie and obstetrics department of the CHU NORD in Marseille. We are going to compare the breathing disorder during sleep of a control group with a group of women with gestational diabetes. A polysomnograph will be run at the included patients' home.
Expected results :
The physiological and hormonal modifications during the pregnancy could favor nocturnal sleep events (snoring, SAHOS and RERA) and its complications as gravidic HPN And gestational diabetes cause maternal and fœtal and morbidity and mortality. We put the hypothesis that limited airflow in association with micro-awakenings in the RERA have a negative impact on the glucose metabolism and favor the gestational diabetes.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant women with gestational diabetes | Experimental | Other: Respiratory disorder assessment during sleep |
| pregnant women without gestational diabetes | Active comparator | Other: Respiratory disorder assessment during sleep |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant woman in the 3rd quarter of pregnancy (24 to 32 weeks amennorhea).
- Presenting a gestational diabetes ou not (=controle group)
- Written and signed consent.
Key exclusion criteria (8 listed)
- Twin pregnancy
- High blood pressure before pregnancy
- Diabetes diagnosed before pregnancy
- Left ventricular ejection fraction below 40%
- Alcohol consumption (more than 7 glaces/day), drugs of type hypnotic, sedative, opioids
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 |
|---|---|---|
| Respiratory disorder assessment during sleep | Other | pregnant women with gestational diabetes, pregnant women without gestational diabetes |
Primary outcome
Respiratory Disturbance Index
Time frame: 4 month
Compare the respiratory disorder during sleep for pregnant women betwwen 2 groups with and without gestational diabetes based on RDI (Respiratory Disturbance Index)
1 secondary outcome
Air flow debit associated to micro awaking during sleep
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Individual participant dataSharing planned: No
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.
Urielle DESALBRES study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory disorder assessment during sleep in people with Respiratory Disorder in Patient With Gestational Diabetes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
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?
Respiratory Disturbance Index (time frame: 4 month). 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 29 Apr 2016.