Status:
COMPLETED
The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life
Lead Sponsor:
Université de Montréal
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Tooth loss and sleep problems are common conditions in elders. Tooth loss can influence sleep quality by changing the shape of the lower face and upper airway. While some studies suggest that sleeping...
Detailed Description
BACKGROUND Aging substantially increases the risk of edentulism and sleep disturbance. These two chronic conditions have serious adverse consequences for the functioning and quality of life of elders...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01868295
Start Date
April 1 2014
End Date
May 1 2019
Last Update
September 18 2019
Active Locations (1)
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1
Université de Montréal
Montreal, Quebec, Canada