Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT01307566
Eligibility Criteria:
Inclusion criteria:
* Type 2 diabetes on stable treatment for the last three months and HbA1C ≥ 7%
* Obstructive Sleep Apnea with and apnea-hypopnea index ≥20
* Acceptance of a therapeutic trial with CPAP
Exclusion criteria:
* Race: non caucasic
* Blood level of hemoglobin \<10 in women or \<11 in men or iron defitiency or hemoglobinopathy
* Glomerular filtration rate \< 30
* Habitual sleeping time \<6 hours per night
* Nocturnal work, shift work or unsual sleeping schedule
* Primary severe insomnia or secondary to restless legs syndrome
* Major or non stable psychiatric disorder
* Treatment with corticosteroids
* Chronic respiratory disorders that may require corticosteroids or cause respiratory insufficiency or FEV1/FVC\<0.7 with FEV1\<50 in spirometry
* Predominant nocturnal hypoventilation pattern
* Cardiac failure
* Alcohol abuse
* Active CPAP treatment
* Previous surgery for sleep apnea
* Severe nasal obstruction
* Illiteracy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT01307566
Study Brief:
Protocol Section:
NCT01307566