Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620601
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Digital Technology for Sleep and Homelessness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnosis and Treatment of Sleep Apnea in Shelter Residents
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HNSLEEP
Brief Summary:
In Canada 35000 people are experiencing homelessness on any night Compared to the general population people experiencing homelessness PEH sleep less and experience increased daytime fatigue A common sleep disorder and treatable cause of morbidity and low quality of life is sleep apnea High prevalence of chronic comorbid disorders of sleep apnea in PEH suggest high prevalence of sleep apnea but the rate of sleep apnea treatment in PEH is very low Also in PEH individual and systemic barriers lead to a high rate of underdiagnosed and untreated sleep apnea Mortality is higher in PEH than the general population and sleep apnea remains a potential silent cause of morbidity and low quality of life in PEH Our goal is to diagnose and treat sleep apnea in people living in shelters and to examine the effect of patient-centered treatment on their quality of life
Detailed Description:
Background
Disadvantaged individuals including people experiencing homelessness are at higher risk of getting infected transmitting disease and having poor health outcomes Access to medical care even within a system of universal health insurance like that of Canada is decreased among people experiencing homelessness but available evidence has demonstrated the efficacy of using telemedicine to reach vulnerable people in remote areas or people experiencing homelessness However at present telemedicine-facilitated care in Canada is predominantly devoid of any technology to evaluate patient vital signals The application of such technology to this population if feasible could have transformational implications for monitoring and management of such disadvantaged populations Currently it is known that there is a greater prevalence of chronic health diseases such as asthma cardiology and respiratory diseases in people experiencing homelessness But there is no literature on the prevalence of obstructive sleep apnea OSA in the people experiencing homelessness OSA is a condition characterized by repeated episodes of breathing cessation during sleep Patients with OSA can suffer from daytime sleepiness fatigue and lack of energy OSA is also associated with the conditions that account for the leading causes of mortality in adults hypertension cardiovascular and cerebrovascular diseases Seeing as the people experiencing homelessness already face many societal barriers to healthcare access it is likely that there may exist a higher prevalence of undiagnosed OSA among the people experiencing homelessness
Rationale
From past studies chronic diseases have been shown to be of higher prevalence in the people experiencing homelessness versus the general population with an emphasis on a high prevalence of asthma and hypertension in the people experiencing homelessness There is already a well-established connection between the prevalence of OSA in patients who have asthma andor hypertension and OSA is already a highly undiagnosed condition in the general population OSA also contributes to many other chronic health conditions Given the strong association of hypertension and asthma with OSA and the above average prevalence of both asthma and hypertension among other chronic diseases in this population it is reasonable to infer that there might also be a high prevalence of undiagnosed OSA among the people experiencing homelessness The use of technology and telemedicine will decrease the barriers in receiving care for people experiencing homelessness and allow for ease of access to diagnose OSA
InclusionExclusion Criteria
The eligibility criteria for participants will include residing in a shelter at the time of recruitment and being 18 years old Participants with allergies to medical tape will be excluded from the study For treatment protocol exclusion criteria for mandibular advancement treatment will be dental and oral health requiring extensive dental treatment or periodontal disease with tooth mobility
Hypotheses
The investigators hypothesize that the prevalence of obstructive sleep apnea in the people experiencing homelessness will exceed that observed in the general population as do the associated conditions of hypertension and asthma Furthermore the investigators hypothesize that the use of technology will help to decrease barriers in diagnosing and providing treatment for OSA
Primary Objectives
1 Assess the prevalence of sleep apnea in shelter residents
2 Evaluate the effects of preferred sleep apnea treatment on quality of life of the people experiencing homelessness
Significance
The investigators anticipate the results of this study to help lower barriers to healthcare and provide better health outcomes for people experiencing homelessness This study will provide insight into the prevalence of OSA in people experiencing homelessness and the feasibility of using technology in telemedicine
Disadvantaged individuals including people experiencing homelessness are at higher risk of getting infected transmitting disease and having poor health outcomes Access to medical care even within a system of universal health insurance like that of Canada is decreased among people experiencing homelessness but available evidence has demonstrated the efficacy of using telemedicine to reach vulnerable people in remote areas or people experiencing homelessness However at present telemedicine-facilitated care in Canada is predominantly devoid of any technology to evaluate patient vital signals The application of such technology to this population if feasible could have transformational implications for monitoring and management of such disadvantaged populations Currently it is known that there is a greater prevalence of chronic health diseases such as asthma cardiology and respiratory diseases in people experiencing homelessness But there is no literature on the prevalence of obstructive sleep apnea OSA in the people experiencing homelessness OSA is a condition characterized by repeated episodes of breathing cessation during sleep Patients with OSA can suffer from daytime sleepiness fatigue and lack of energy OSA is also associated with the conditions that account for the leading causes of mortality in adults hypertension cardiovascular and cerebrovascular diseases Seeing as the people experiencing homelessness already face many societal barriers to healthcare access it is likely that there may exist a higher prevalence of undiagnosed OSA among the people experiencing homelessness
Rationale
From past studies chronic diseases have been shown to be of higher prevalence in the people experiencing homelessness versus the general population with an emphasis on a high prevalence of asthma and hypertension in the people experiencing homelessness There is already a well-established connection between the prevalence of OSA in patients who have asthma andor hypertension and OSA is already a highly undiagnosed condition in the general population OSA also contributes to many other chronic health conditions Given the strong association of hypertension and asthma with OSA and the above average prevalence of both asthma and hypertension among other chronic diseases in this population it is reasonable to infer that there might also be a high prevalence of undiagnosed OSA among the people experiencing homelessness The use of technology and telemedicine will decrease the barriers in receiving care for people experiencing homelessness and allow for ease of access to diagnose OSA
InclusionExclusion Criteria
The eligibility criteria for participants will include residing in a shelter at the time of recruitment and being 18 years old Participants with allergies to medical tape will be excluded from the study For treatment protocol exclusion criteria for mandibular advancement treatment will be dental and oral health requiring extensive dental treatment or periodontal disease with tooth mobility
Hypotheses
The investigators hypothesize that the prevalence of obstructive sleep apnea in the people experiencing homelessness will exceed that observed in the general population as do the associated conditions of hypertension and asthma Furthermore the investigators hypothesize that the use of technology will help to decrease barriers in diagnosing and providing treatment for OSA
Primary Objectives
1 Assess the prevalence of sleep apnea in shelter residents
2 Evaluate the effects of preferred sleep apnea treatment on quality of life of the people experiencing homelessness
Significance
The investigators anticipate the results of this study to help lower barriers to healthcare and provide better health outcomes for people experiencing homelessness This study will provide insight into the prevalence of OSA in people experiencing homelessness and the feasibility of using technology in telemedicine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None