Sleep ApnoeaADSANCT02403141
Abu Dhabi Sleep Apnea (ADSA) Study
An observational study of Sleep Apnoea, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
Trial summary
Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing awareness, remains under-diagnosed. There is a close association between OSA and obesity; 60-70% of patients diagnosed with OSA are either obese or overweight [1]. OSA is also very common among patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnoea
- What is being tested?
- Questionnaire
- How many people
- 1,400 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Mar 2015to Mar 2017
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients over the age of 18 attending ICLDC will be offered the option of taking part in the study. Those agreeing to participate will be asked to fill in a questionnaire.
Who may be able to join
- Participants aged between 18-64 years old. Both Gender male and female.
Who cannot join
- Paediatrics below the age of 18. Any participant who is unable to take part
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Imperial College London Diabetes Centre
Abu Dhabi, P.O Box 48338
About this study
Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing awareness, remains under-diagnosed. There is a close association between OSA and obesity; 60-70% of patients diagnosed with OSA are either obese or overweight [1]. OSA is also very common among patients with type 2 diabetes. Type 2 Diabetes Mellitus (T2DM) has reached epidemic status in the Gulf region. OSA worsens insulin resistance and leads to weight gain through sleep disturbance [2]. Several mechanisms have been proposed for the associations of OSA with diabetes and obesity [3]. At present there is little available information regarding the prevalence of OSA in the UAE, the relationship with T2DM and obesity, and the impact of OSA on health outcomes in the Emirati population. This research will explore these relationships and inform public health decisions regarding diagnostic pathways, service provision and treatment protocols.
- Conditions
- Sleep Apnoea
- Being tested
- Questionnaire
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Normal glucose tolerance | Patients with normal fasting glucose. Blood glucose less than 5.6mmol/L Receives: Other: Questionnaire | |
| Impaired fasting glycaemia | Patients with blood glucose between 5.6mmol/L - 7mmol/L Receives: Other: Questionnaire | |
| Type 2 diabetes | Patients with blood glucose higher than 7mmol/L and negative IA2 and GAD antibodies. Receives: Other: Questionnaire | |
| Type 1 diabetes | Patients on insulin and with positive IA2 and/or GAD antibodies. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective (Establishing the prevalence of OSA in the study population.)
Establishing the prevalence of OSA in the study population.
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 posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApnoeaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London Diabetes Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nader Lessan, MD, Imperial College London Diabetes Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403141
- Sponsor's protocol ID
- IREC020
- Acronym
- ADSA
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abu Dhabi Sleep Apnea (ADSA) Study
- ClinicalTrials.gov ID
- NCT02403141
- Acronym / sponsor ID
- ADSA / IREC020
- Conditions
- Sleep Apnoea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Imperial College London Diabetes CentreUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 31 Mar 2015 (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.
Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing awareness, remains under-diagnosed. There is a close association between OSA and obesity; 60-70% of patients diagnosed with OSA are either obese or overweight [1]. OSA is also very common among patients with type 2 diabetes. Type 2 Diabetes Mellitus (T2DM) has reached epidemic status in the Gulf region. OSA worsens insulin resistance and leads to weight gain through sleep disturbance [2]. Several mechanisms have been proposed for the associations of OSA with diabetes and obesity [3]. At present there is little available information regarding the prevalence of OSA in the UAE, the relationship with T2DM and obesity, and the impact of OSA on health outcomes in the Emirati population. This research will explore these relationships and inform public health decisions regarding diagnostic pathways, service provision and treatment protocols.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal glucose tolerance | – | Other: QuestionnairePatients with normal fasting glucose. Blood glucose less than 5.6mmol/L |
| Impaired fasting glycaemia | – | Other: QuestionnairePatients with blood glucose between 5.6mmol/L - 7mmol/L |
| Type 2 diabetes | – | Other: QuestionnairePatients with blood glucose higher than 7mmol/L and negative IA2 and GAD antibodies. |
| Type 1 diabetes | – | Other: QuestionnairePatients on insulin and with positive IA2 and/or GAD antibodies. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients over the age of 18 attending ICLDC will be offered the option of taking part in the study. Those agreeing to participate will be asked to fill in a questionnaire.
Key inclusion criteria (1 listed)
- Participants aged between 18-64 years old. Both Gender male and female.
Key exclusion criteria (1 listed)
- Paediatrics below the age of 18. Any participant who is unable to take part
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 |
|---|---|---|
| Questionnaire | Other | Impaired fasting glycaemia, Normal glucose tolerance, Type 1 diabetes, Type 2 diabetes |
Primary outcome
Primary objective (Establishing the prevalence of OSA in the study population.)
Time frame: 3 months
Establishing the prevalence of OSA in the study population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnoea, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. 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 United Arab Emirates. 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?
Primary objective (Establishing the prevalence of OSA in the study population.) (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 3 Mar 2017.