Type 1 Diabetes, Sleep Apnea SyndromeDIASOMNCT01935765
Sleep Apnea in Type 1 Diabetes
A study testing Polysomnography, Evaluation of the autonomous nervous system and Clinical examination of the sleep in people with Type 1 Diabetes, Sleep Apnea Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in some studies diabetes status. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Sleep Apnea Syndrome
- What is being tested?
- Polysomnography, Evaluation of the autonomous nervous system and Clinical examination of the sleep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Sep 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 99 Type 1 diabetic patients
- man or woman aged 18 to 60 years
- diagnosed since at least a year
- having signed a consent
- with in a national insurance scheme
- and 46 healthy volunteers matched by age , gender and body mass index
Show all 9Show fewer
- man or woman aged 18 to 60 years
- having signed a consent
- with in a national insurance scheme
Who cannot join
- for both
- sleep apnea syndrome already known
- acute respiratory or cardiovascular disease
- impairment of consciousness
- sepsis
- cirrhosis
Show all 11Show fewer
- hypnotic, opiate or psychotropic drug treatment 2 weeks ago
- Pregnant or breast-feeding woman
- Do not speak French
- Benefiting from a legal protective measure
- diabet 1 or 2 just for volunteers people
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Apnea in Type 1 Diabetes : Prevalence, Role of Glycemic Control and Autonomic Neuropathy
Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in some studies diabetes status. Few data are available for type 1 diabetes but suggest that the prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of sleep apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and a control group matched by age, gender and body mass index. The secondary objective is to determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the diabetic group.
Read the detailed description
Diagnostic protocol designed to evaluate if if sleep apnea syndrome is more frequent in type 1 diabetes than in general population and therefore deserves to be more systematically suspected and actively diagnosed in this patients. Sleep apnea syndrome is a heavy burden as a matter of quality of life: it is responsible for fatigue, diurnal sleepiness, cognitive impairment, poor and /or non restorative sleep, morning headaches, depressive mood…Adequate treatment provides a rapid and, most of the time, complete relief of these symptoms.
On an other hand, Sleep Apnea is and independent risk factor for cardiovascular mortality and morbidity in young and middle aged subjects, also reversed by treatment. It might be therefore important for type 1 diabetic patients who have already an increased cardiovascular risk to be properly diagnosed for sleep apnea. A systematic screening for sleep apnea is already recommended for patients with type 2 diabetes by experts.
A secondary objective is to determine if the presence of a sleep apnea syndrome in type 1 diabetic patients is associated to an autonomic neuropathy, a poor glycemic control , a poorer quality of life , a poorer quality of sleep, more severe cardiovascular consequences and biological impairment.
- Conditions
- Type 1 Diabetes, Sleep Apnea Syndrome
- Being tested
- Polysomnography, Evaluation of the autonomous nervous system, Clinical examination of the sleep, Clinical examination of diabetology, Biological dosages
- Keywords
- Type 1 diabetes, sleep apnea, polysomnography,, autonomic neuropathy, intima media thickness
- Medical subject headings
- Diabetes Mellitus, Type 1, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
Diabetes people: Examination diagnosis of the sleep apnea A night at the hospital
Evaluation of the autonomous nervous systemOther
blood pressure, Heart frequence, deep breath, Orthostatism, Vasalva, Low blood pressure orthostatic
Clinical examination of the sleepOther
Functional signs, collection of medical histories and associated pathologies, Pittsburgh Sleep Quality Index PSQI, Functional Outcomes of Sleep Questionnaire FOSQ, Epworth Sleepiness Scale ESS, Hospital Anxiety and Depression scale HAD
Clinical examination of diabetologyOther
history of diabet, observance, ophthalmological, renal, macroangiopathic and neuronal complications, Toronto scale, Diabetes Quality of Life (DQOL) Questionnaire
Biological dosagesOther
Hematology, glycemia, lipids, CRP, creatinine, ferritin, glycosylated hemoglobin, transaminase, microalbuminuria, urine test
Electrocardiogram (ECG)Other
Electrocardiogram (ECG)
Carotid echographyOther
Carotid echography
Blood pressureOther
Blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Diabetes people | Experimental | 99 Type 1 diabetic patients aged 18 to 60 years, diagnosed since at least a year Receives: Other: Polysomnography; Other: Evaluation of the autonomous nervous system; Other: Clinical examination of the sleep; Other: Clinical examination of diabetology; Other: Biological dosages; Other: Electrocardiogram (ECG); Other: Carotid echography; Other: Blood pressure |
| healthy volunteers (controll group) | Experimental | 46 healthy volunteers matched by age, gender and body mass index Receives: Other: Polysomnography; Other: Evaluation of the autonomous nervous system; Other: Clinical examination of the sleep; Other: Biological dosages; Other: Electrocardiogram (ECG); Other: Carotid echography; Other: Blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers
Determine if prevalence of the sleep apnea syndrome is more raised at the patient's diabetics of type 1 (DT1) than in the general population and to collect elements to specify the determiners of this association (presence of an autonomous neuropathy and glycemic balance).
sleep apnea syndrome as defined by the International Classification of Sleep Disorders 2
Measured: 3 months
Secondary outcomes (5)
Precise if glycemic balance as defined by glycosylated hemoglobin<7% during the last three months is associated or not to sleep apnea syndrome
Compare diabetic subjects with or without sleep apnea regarding the rate of poorly controlled diabetes (determined by the level of glycosylated haemoglobin)
Measured: 3 months
Precise if the presence of an autonomic neuropathy (positive at 2 tests) is associated or not to sleep apnea syndrome
Compare diabetic subjects with or without sleep apnea regarding presence of autonomic neuropathy determined by clinical assessment
Measured: 3 months
Compare the patients with or without sleep apnea regarding consequences especially cardiovascular markers and coagulation factors
Compare diabetic subjects with or without sleep apnea regarding other cardiovascular risk factors and consequences (intima media thickness)
Measured: 3 months
Determine if the presence of sleep apnea syndrome has an impact upon quality of life and diabetes complications, micro or macroangiopathy
Compare diabetic subjects with or without sleep apnea regarding quality of sleep
Measured: 3 months
Precise clinical symptoms in DT1 patients with Sleep apnea syndrome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes, Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Véronique Viot-Blanc, MD, Study director, Lariboisiere Hospital, APHPPierre-Jean Guillausseau, MD, PhD, Principal investigator, Lariboisiere Hopistal, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935765
- Sponsor's protocol ID
- P111009
- Acronym
- DIASOM
- Status last verified
- Dec 2019
- First submitted
- 2 Sep 2013
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea in Type 1 Diabetes : Prevalence, Role of Glycemic Control and Autonomic Neuropathy
- ClinicalTrials.gov ID
- NCT01935765
- Acronym / sponsor ID
- DIASOM / P111009
- Conditions
- Type 1 Diabetes, Sleep Apnea Syndrome
- Keywords
- Type 1 diabetes, sleep apnea, polysomnography,, autonomic neuropathy, intima media thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2013 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 5 Sep 2013 (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.
Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in some studies diabetes status. Few data are available for type 1 diabetes but suggest that the prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of sleep apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and a control group matched by age, gender and body mass index. The secondary objective is to determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the diabetic group.
Detailed description
Diagnostic protocol designed to evaluate if if sleep apnea syndrome is more frequent in type 1 diabetes than in general population and therefore deserves to be more systematically suspected and actively diagnosed in this patients. Sleep apnea syndrome is a heavy burden as a matter of quality of life: it is responsible for fatigue, diurnal sleepiness, cognitive impairment, poor and /or non restorative sleep, morning headaches, depressive mood…Adequate treatment provides a rapid and, most of the time, complete relief of these symptoms.
On an other hand, Sleep Apnea is and independent risk factor for cardiovascular mortality and morbidity in young and middle aged subjects, also reversed by treatment. It might be therefore important for type 1 diabetic patients who have already an increased cardiovascular risk to be properly diagnosed for sleep apnea. A systematic screening for sleep apnea is already recommended for patients with type 2 diabetes by experts.
A secondary objective is to determine if the presence of a sleep apnea syndrome in type 1 diabetic patients is associated to an autonomic neuropathy, a poor glycemic control , a poorer quality of life , a poorer quality of sleep, more severe cardiovascular consequences and biological impairment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes people | Experimental | Other: Polysomnography, Other: Evaluation of the autonomous nervous system, Other: Clinical examination of the sleep, Other: Clinical examination of diabetology, Other: Biological dosages, Other: Electrocardiogram (ECG), Other: Carotid echography, Other: Blood pressure99 Type 1 diabetic patients aged 18 to 60 years, diagnosed since at least a year |
| healthy volunteers (controll group) | Experimental | Other: Polysomnography, Other: Evaluation of the autonomous nervous system, Other: Clinical examination of the sleep, Other: Biological dosages, Other: Electrocardiogram (ECG), Other: Carotid echography, Other: Blood pressure46 healthy volunteers matched by age, gender and body mass index |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 99 Type 1 diabetic patients
- and 46 healthy volunteers matched by age , gender and body mass index
Key exclusion criteria (11 listed)
- for both
- sleep apnea syndrome already known
- acute respiratory or cardiovascular disease
- impairment of consciousness
- sepsis
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 |
|---|---|---|
| PolysomnographyDiabetes people: Examination diagnosis of the sleep apnea A night at the hospital | Other | Diabetes people, healthy volunteers (controll group) |
| Evaluation of the autonomous nervous systemblood pressure, Heart frequence, deep breath, Orthostatism, Vasalva, Low blood pressure orthostatic | Other | Diabetes people, healthy volunteers (controll group) |
| Clinical examination of the sleepFunctional signs, collection of medical histories and associated pathologies, Pittsburgh Sleep Quality Index PSQI, Functional Outcomes of Sleep Questionnaire FOSQ, Epworth Sleepiness Scale ESS, Hospital Anxiety and Depression scale HAD | Other | Diabetes people, healthy volunteers (controll group) |
| Clinical examination of diabetologyhistory of diabet, observance, ophthalmological, renal, macroangiopathic and neuronal complications, Toronto scale, Diabetes Quality of Life (DQOL) Questionnaire | Other | Diabetes people |
| Biological dosagesHematology, glycemia, lipids, CRP, creatinine, ferritin, glycosylated hemoglobin, transaminase, microalbuminuria, urine test | Other | Diabetes people, healthy volunteers (controll group) |
| Electrocardiogram (ECG)Electrocardiogram (ECG) | Other | Diabetes people, healthy volunteers (controll group) |
| Carotid echographyCarotid echography | Other | Diabetes people, healthy volunteers (controll group) |
| Blood pressureBlood pressure | Other | Diabetes people, healthy volunteers (controll group) |
Primary outcome
Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers
Time frame: 3 months
Determine if prevalence of the sleep apnea syndrome is more raised at the patient's diabetics of type 1 (DT1) than in the general population and to collect elements to specify the determiners of this association (presence of an autonomous neuropathy and glycemic balance). sleep apnea syndrome as defined by the International Classification of Sleep Disorders 2
5 secondary outcomes
Precise if glycemic balance as defined by glycosylated hemoglobin<7% during the last three months is associated or not to sleep apnea syndrome
Time frame: 3 months
Precise if the presence of an autonomic neuropathy (positive at 2 tests) is associated or not to sleep apnea syndrome
Time frame: 3 months
Compare the patients with or without sleep apnea regarding consequences especially cardiovascular markers and coagulation factors
Time frame: 3 months
Determine if the presence of sleep apnea syndrome has an impact upon quality of life and diabetes complications, micro or macroangiopathy
Time frame: 3 months
Precise clinical symptoms in DT1 patients with Sleep apnea syndrome
Time frame: 3 months
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 5 Dec 2019.
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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.
Véronique Viot-Blanc, MD study director
Lariboisiere Hospital, APHP
Pierre-Jean Guillausseau, MD, PhD principal investigator
Lariboisiere Hopistal, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography, Evaluation of the autonomous nervous system and Clinical examination of the sleep in people with Type 1 Diabetes, Sleep Apnea Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 9 inclusion and 11 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 5 Dec 2019. 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?
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?
Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers (time frame: 3 months). 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 5 Dec 2019.