Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649929
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Nuestro Sueno Cultural Adaptation of a Couples Intervention to Improve PAP Adherence and Sleep Health Among Latino Couples With Implications for Alzheimers Disease Risk
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nuestro Sueno Cultural Adaptation of a Couples Intervention to Improve PAP Adherence and Sleep Health Among Latino Couples With Implications for Alzheimers Disease Risk
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The goal of this clinical trial is to learn if the culturally adapted couples sleep health intervention Nuestro Sueno improves positive airway pressure PAP use and sleep among Hispanic couples in which one partner was diagnosed with sleep apnea and starting PAP treatment
The main questions are
1 Does Nuestro sueno improve the patients PAP use over the first 3 months of using it compared to an information control
2 Does Nuestro sueno improve sleep quality for both the patient and partner compared to an information control
3 Does Nuestro sueno improve other aspects of life including quality of life and memory compared to an information control
The main questions are
1 Does Nuestro sueno improve the patients PAP use over the first 3 months of using it compared to an information control
2 Does Nuestro sueno improve sleep quality for both the patient and partner compared to an information control
3 Does Nuestro sueno improve other aspects of life including quality of life and memory compared to an information control
Detailed Description:
Latino adults in the United States US are 15 times more likely to develop Alzheimers disease AD and related dementias ADRD compared to non-Hispanic white adults Obstructive sleep apnea OSA affects 98 of Latino adults and confers a five-fold increased risk of AD diagnosis5 Consequences also extend to the bedpartner as bedpartners of those with OSA experience significant sleep disturbances including sleep fragmentation and 3 times greater risk of insomnia Given solid mechanistic links between both OSA and insomnia and ADRD risk effective OSA treatment has the potential to promote healthy cognitive aging and reduce ADRD risk for both partners While the front-line treatment for OSA positive airway pressure PAP is highly effective at reducing OSA symptoms and may reduce or forestall ADRD risk its potential is severely diminished as up to 80 of patients are non-adherent Extant PAP adherence interventions are limited in that they are exclusively focused on the individual neglecting to consider the role of the bedpartner in treatment and developed primarily in non-Hispanic white populations Therefore there is a critical need to develop evidence-based and culturally-adapted interventions that address the impact of OSA and its treatment on both partners and within a culturally-tailored framework The goal of this R6133 proposal is to develop and test Nuestro Sueño a culturally-adapted intervention to promote PAP adherence and sleep health among Latino couples We will conduct a randomized clinical trial to evaluate the feasibility treatment satisfaction and preliminary efficacy of Nuestro Sueño versus information control IC in a sample of 80 OSA patients and their partners ie 40 couples per treatment arm across two sites Utah and Arizona The intervention focuses specifically on the interpersonal mechanisms of enhancing dyadic coping and communication using intervention materials resonant with cultural beliefs and values If successful Nuestro Sueño an innovative and culturally-adapted intervention has the potential to significantly advance the treatment of OSA and may elucidate a critical modifiable target of prevention and intervention to promote healthy aging and reduce disparities in ADRD risk among Latino couples
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