Sleep Apnea, ObstructiveNCT01868295
The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life
A study testing Sleeping with denture in people with Sleep Apnea, Obstructive, run by Université de Montréal at 1 site in Canada.
Trial 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 without dentures can worsen sleep quality in toothless elders, others suggest the opposite. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Sleeping with denture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to May 2019
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life: a Randomized Cross-Over Trial
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.
We 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.
Read the 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 and place a significant burden on the Canadian health care system. Edentulism can disturb sleep through the alteration of the craniofacial structure and surrounding soft tissue. However, the effect of prosthetic rehabilitation of edentulism on sleep quality is still not well understood. While there is some evidence suggesting that not wearing dentures at night can worsen sleep quality and lead to severe sleep disturbance in edentate elders, there are also studies that have suggested the opposite. The current controversy does not permit clinicians to engage in evidence-based clinical decision-making. To enable development of clinical practice guidelines, solid evidence is required. This proposed randomized trial represents the logical next step of the clinical investigations conducted by our multidisciplinary expert team of oral health and sleep researchers from the University of Montreal, McGill University, University of British Colombia, and Laval University. Our pilot data suggest that edentate elders who wear dentures at night experience more daytime sleepiness than those who do not. Furthermore, we found that the nocturnal use of dentures may increase the risk of apneic events in seniors affected by mild sleep disturbance.
OBJECTIVES
The primary objective of this study is to test whether nocturnal denture wear has an effect on sleep quality and daytime sleepiness of edentate elders with moderate to severe sleep apnea. Our secondary objective is to test whether nocturnal denture wear affects on the oral-health-related quality of life of edentate elders with moderate to severe sleep apnea. . The third objective is to identify moderators of effect of nocturnal denture wear so as to determine patient subgroups where the intervention is more efficacious.
METHODS
We will carry out a single-blind randomized cross-over clinical trial, into which 70 edentate elders will be enrolled. Study participants will be assigned to wear and not wear their denture in alternate orders for two periods of 30 days. The primary outcome will be sleep quality (as measured by the apnea-hypopnea index). The secondary outcomes will be daytime sleepiness and oral health-related quality of life. Outcome assessments will be carried out with portable polysomnography, the Epworth Sleepiness Scale, and an oral health-related quality of life questionnaire. Explanatory variables will include socio-demographic factors, medical, and anthropometric (weight, height) variables, oropharyngeal morphology, oral and prosthesis characteristics, as well as perceived general health quality of life. These characteristics will be assessed by clinical examination, 3D imaging (Cone Beam Computed Tomography) of the cranio-facial structure, as well as validated questionnaires. Assessments will be done at baseline and at the end of each of the 30-day intervention periods. Linear mixed-effects regression models for repeated measures will be fitted to test the study hypotheses. The main analyses will be based on the intention-to-treat principle. To assess the robustness of the findings to potential incomplete adherence, sensitivity analyses will be conducted while applying the per-protocol principle.
SIGNIFICANCE
Our findings will have important clinical implications and will help to resolve the current uncertainty about the effects of nocturnal wearing of dentures in the edentate elderly population. This practice-relevant evidence could enable the development of preventive approaches to improve sleep quality of the older population and, thereby, improve their well-being and quality of life. This evidence will be shared with the Canadian Dental Association, the Canadian and the American Academy of Dental Sleep Medicine, and the Canadian Sleep Society to assist these agencies in producing practice guidelines for primary care providers, dentists, and sleep medicine specialists involved in the care of edentate elders.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Sleeping with denture
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeping with dentureBehavioural
Sleeping with denture at night
| Study group | Role | What they receive |
|---|---|---|
| Sleeping with denture | Experimental | Sleeping with denture at night Receives: Behavioral: Sleeping with denture |
| Sleeping without denture | No intervention | Sleeping without denture at night |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Sleep quality is measured by the AHI. The AHI index will be measured by use of diagnostic portable polysomnography.
Measured: 30 days
Secondary outcomes (2)
Daytime sleepiness
The Sleepiness Scale (ESS) will be used to assess perceived daytime sleepiness. Participants will be asked to rate their chance of dozing in eight different sedentary situations.
Measured: 30 days
Oral health related quality of life
Oral health related quality of life will be measured by means of the oral health impact profile (OHIP-20). This instrument is a disease-specific measure of people's perceptions of their physical, psychological,and social impacts of oral health on their quality of life.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startApr 2014
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Emami, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868295
- Sponsor's protocol ID
- FMD-UdeM-EE-2013a
- Status last verified
- Sep 2019
- First submitted
- 29 May 2013
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chen H, Emami E, Kauffmann C, Rompre P, Almeida F, Schmittbuhl M, van der Stelt P, Ge S, Lavigne G, Huynh N. Airway Phenotypes and Nocturnal Wearing of Dentures in Elders with Sleep Apnea. J Dent Res. 2023 Mar;102(3):263-269. doi: 10.1177/00220345221133278. Epub 2022 Nov 4.
PubMed 36333889Chen H, Elham E, Li Y, Ge S, Schmittbuhl M, Lavigne G, van der Stelt PF, Huynh N. Comparison of anatomic and aerodynamic characteristics of the upper airway among edentulous mild, moderate, and severe obstructive sleep apnea in older adults. J Clin Sleep Med. 2022 Mar 1;18(3):759-768. doi: 10.5664/jcsm.9716.
PubMed 34636319Emami E, Lavigne G, Feine JS, Karp I, Rompre PH, Almeida FR, Huynh NT. Effects of nocturnal wearing of dentures on the quality of sleep and oral-health-related quality in edentate elders with untreated sleep apnea: a randomized cross-over trial. Sleep. 2021 Oct 11;44(10):zsab101. doi: 10.1093/sleep/zsab101.
PubMed 33955479Emami E, Nguyen PT, Almeida FR, Feine JS, Karp I, Lavigne G, Huynh N. The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial. Trials. 2014 Sep 13;15:358. doi: 10.1186/1745-6215-15-358.
PubMed 25218696
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life: a Randomized Cross-Over Trial
- ClinicalTrials.gov ID
- NCT01868295
- Acronym / sponsor ID
- FMD-UdeM-EE-2013a
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 4 Jun 2013 (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.
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.
We 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.
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 and place a significant burden on the Canadian health care system. Edentulism can disturb sleep through the alteration of the craniofacial structure and surrounding soft tissue. However, the effect of prosthetic rehabilitation of edentulism on sleep quality is still not well understood. While there is some evidence suggesting that not wearing dentures at night can worsen sleep quality and lead to severe sleep disturbance in edentate elders, there are also studies that have suggested the opposite. The current controversy does not permit clinicians to engage in evidence-based clinical decision-making. To enable development of clinical practice guidelines, solid evidence is required. This proposed randomized trial represents the logical next step of the clinical investigations conducted by our multidisciplinary expert team of oral health and sleep researchers from the University of Montreal, McGill University, University of British Colombia, and Laval University. Our pilot data suggest that edentate elders who wear dentures at night experience more daytime sleepiness than those who do not. Furthermore, we found that the nocturnal use of dentures may increase the risk of apneic events in seniors affected by mild sleep disturbance.
OBJECTIVES
The primary objective of this study is to test whether nocturnal denture wear has an effect on sleep quality and daytime sleepiness of edentate elders with moderate to severe sleep apnea. Our secondary objective is to test whether nocturnal denture wear affects on the oral-health-related quality of life of edentate elders with moderate to severe sleep apnea. . The third objective is to identify moderators of effect of nocturnal denture wear so as to determine patient subgroups where the intervention is more efficacious.
METHODS
We will carry out a single-blind randomized cross-over clinical trial, into which 70 edentate elders will be enrolled. Study participants will be assigned to wear and not wear their denture in alternate orders for two periods of 30 days. The primary outcome will be sleep quality (as measured by the apnea-hypopnea index). The secondary outcomes will be daytime sleepiness and oral health-related quality of life. Outcome assessments will be carried out with portable polysomnography, the Epworth Sleepiness Scale, and an oral health-related quality of life questionnaire. Explanatory variables will include socio-demographic factors, medical, and anthropometric (weight, height) variables, oropharyngeal morphology, oral and prosthesis characteristics, as well as perceived general health quality of life. These characteristics will be assessed by clinical examination, 3D imaging (Cone Beam Computed Tomography) of the cranio-facial structure, as well as validated questionnaires. Assessments will be done at baseline and at the end of each of the 30-day intervention periods. Linear mixed-effects regression models for repeated measures will be fitted to test the study hypotheses. The main analyses will be based on the intention-to-treat principle. To assess the robustness of the findings to potential incomplete adherence, sensitivity analyses will be conducted while applying the per-protocol principle.
SIGNIFICANCE
Our findings will have important clinical implications and will help to resolve the current uncertainty about the effects of nocturnal wearing of dentures in the edentate elderly population. This practice-relevant evidence could enable the development of preventive approaches to improve sleep quality of the older population and, thereby, improve their well-being and quality of life. This evidence will be shared with the Canadian Dental Association, the Canadian and the American Academy of Dental Sleep Medicine, and the Canadian Sleep Society to assist these agencies in producing practice guidelines for primary care providers, dentists, and sleep medicine specialists involved in the care of edentate elders.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeping with denture | Experimental | Behavioral: Sleeping with dentureSleeping with denture at night |
| Sleeping without denture | No intervention | –Sleeping without denture at night |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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);
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 |
|---|---|---|
| Sleeping with dentureSleeping with denture at night | Behavioural | Sleeping with denture |
Primary outcome
Sleep quality
Time frame: 30 days
Sleep quality is measured by the AHI. The AHI index will be measured by use of diagnostic portable polysomnography.
2 secondary outcomes
Daytime sleepiness
Time frame: 30 days
Oral health related quality of life
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Derived from this study: PubMed 36333889Chen H, Emami E, Kauffmann C, Rompre P, Almeida F, Schmittbuhl M, van der Stelt P, Ge S, Lavigne G, Huynh N. Airway Phenotypes and Nocturnal Wearing of Dentures in Elders with Sleep Apnea. J Dent Res. 2023 Mar;102(3):263-269. doi: 10.1177/00220345221133278. Epub 2022 Nov 4.
- Derived from this study: PubMed 34636319Chen H, Elham E, Li Y, Ge S, Schmittbuhl M, Lavigne G, van der Stelt PF, Huynh N. Comparison of anatomic and aerodynamic characteristics of the upper airway among edentulous mild, moderate, and severe obstructive sleep apnea in older adults. J Clin Sleep Med. 2022 Mar 1;18(3):759-768. doi: 10.5664/jcsm.9716.
- Derived from this study: PubMed 33955479Emami E, Lavigne G, Feine JS, Karp I, Rompre PH, Almeida FR, Huynh NT. Effects of nocturnal wearing of dentures on the quality of sleep and oral-health-related quality in edentate elders with untreated sleep apnea: a randomized cross-over trial. Sleep. 2021 Oct 11;44(10):zsab101. doi: 10.1093/sleep/zsab101.
- Derived from this study: PubMed 25218696Emami E, Nguyen PT, Almeida FR, Feine JS, Karp I, Lavigne G, Huynh N. The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial. Trials. 2014 Sep 13;15:358. doi: 10.1186/1745-6215-15-358.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Sleeping with denture in people with Sleep Apnea, Obstructive, run by Université de Montréal at 1 site in Canada.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 18 Sep 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep quality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868295, which also lists 4 linked publications.
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 18 Sep 2019.