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 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT01868295
Eligibility Criteria:
Inclusion Criteria:
* be aged 65 years or older; have worn a complete set of removable dentures in the last year AND not have worn a denture during sleep in the last 12 months;
* have an AHI ≥ 10 at screening
* have an adequate understanding of written and spoken English or French;
* be able to understand and respond to the questionnaires used in the study;
* agree to follow the research study instructions;
* agree to maximally adhere to the allocated sequence of interventions;
* consume no alcohol and not work late at night on the day before polysomnography.
Exclusion Criteria:
* have an AHI \< 10;
* have any severe cardiologic, neurologic, psychological, or psychiatric condition, respiratory disease, acute airway infection or any other health condition that jeopardizes sleep;
* have a score of 24 or less on the mini-mental state evaluation;
* regularly consume more than 2 alcoholic beverages per day for females and 3 for males;
* are taking medication or any illicit drug that will affect sleep architecture or respiratory muscle activity (i.e., hypnotics, psychostimulants, anticonvulsant, or antipsychotics);
* are on regular continuous positive airway pressure therapy or nocturnal supplemental oxygen;
* have sleepiness deemed to be unsafe and requiring urgent treatment;
* feel that the trial would negatively influence their private life.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01868295
Study Brief:
Protocol Section:
NCT01868295