[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100199118":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":23,"responsibleParty":35,"collaborators":18,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":18,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":18,"enrollmentInfo":49,"targetDuration":18,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":18,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Université de Montréal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sleeping with denture","EXPERIMENTAL","Sleeping with denture at night",[13],"Behavioral: Sleeping with denture",{"label":15,"type":16,"description":17,"interventionNames":18},"Sleeping without denture","NO_INTERVENTION","Sleeping without denture at night",null,[20],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":18},"BEHAVIORAL",[9],[24],{"facility":5,"status":18,"city":25,"state":26,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":18},"Montreal","Quebec","Canada","CA",{"type":30,"coordinates":31},"Point",[32,33],-73.58781,45.50884,{"lat":33,"lon":32},{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Elham Emami","Professor","100199118","the-effect-of-nocturnal-wear-of-dentures-on-sleep-and-oral-health-related-quality-of-life-100199118",false,"NCT01868295","The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life","The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life: a Randomized Cross-Over Trial","Inclusion Criteria:\n\n* 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;\n* have an AHI ≥ 10 at screening\n* have an adequate understanding of written and spoken English or French;\n* be able to understand and respond to the questionnaires used in the study;\n* agree to follow the research study instructions;\n* agree to maximally adhere to the allocated sequence of interventions;\n* consume no alcohol and not work late at night on the day before polysomnography.\n\nExclusion Criteria:\n\n* have an AHI \\\u003C 10;\n* have any severe cardiologic, neurologic, psychological, or psychiatric condition, respiratory disease, acute airway infection or any other health condition that jeopardizes sleep;\n* have a score of 24 or less on the mini-mental state evaluation;\n* regularly consume more than 2 alcoholic beverages per day for females and 3 for males;\n* are taking medication or any illicit drug that will affect sleep architecture or respiratory muscle activity (i.e., hypnotics, psychostimulants, anticonvulsant, or antipsychotics);\n* are on regular continuous positive airway pressure therapy or nocturnal supplemental oxygen;\n* have sleepiness deemed to be unsafe and requiring urgent treatment;\n* feel that the trial would negatively influence their private life.",true,"ALL","65 Years",{"count":50,"type":51},70,"ACTUAL","INTERVENTIONAL",[54],"NA","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 without dentures can worsen sleep quality in toothless elders, others suggest the opposite. Consequently, there are currently no evidence-based practice guidelines regarding whether dentures should be used at night, and dentists and doctors do not know how to properly advise their patients on these issues. To address this knowledge gap, over the past 5 years we have carried out research examining the quality of sleep of a group of edentulous elders. In addition, we conducted a pilot study to examine the link between night-time denture wear and sleep. Our results indicate that edentulous elders who wore their dentures at night had high levels of daytime sleepiness. Furthermore, use of dentures at night seemed to increase the risk of apneic events in those elders who had mild sleep disturbance. While intriguing, these results require confirmation in larger samples. In line with our previous research, the aim of the proposed study is to produce reliable evidence that clinical practice guidelines could be based on and which could be used by dentists and doctors who treat toothless elders.\n\nWe will enroll 70 toothless elders who will be randomly assigned to wear and not wear their dentures at night for two periods of 30 days. Sleep studies will be conducted at the homes of participants. The participants will also be asked to respond to questions on sleep quality and oral health-related quality of life. Ultimately, the results of this study will help improve the health and quality of life of millions of elders in Canada and around the world.",[57],"Sleep Apnea, Obstructive","COMPLETED","2019-09-15",{"date":61,"type":51},"2019-09-18",{"date":63,"type":18},"2014-04",{"date":65,"type":51},"2019-05",{"name":5,"class":6},1]