Clinical trial NCT06227572: Cognition After OSA Treatment Among Native American People (CATNAP)
Official title: Cognition After Obstructive Sleep Apnea (OSA) Treatment Among Native American People (CATNAP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Cognitive Change
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: Missouri Breaks Industries Research, Inc.
name: University of Washington
name: University of Minnesota
First posted: 2024-01-29
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research project will develop and implement a motivational interviewing and electronic messaging intervention to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias in American Indians. The project will work with American Indian Elders, aged 50 years and older, from three Northern Plains Reservations and surrounding communities. A total of 300 American Indian elders with a confirmed OSA diagnosis and prescribed PAP therapy will be randomized to receive usual care consisting of PAP therapy alone (control condition) or usual care plus the culturally informed CATNAP MI component (intervention condition).

Detailed description: The investigators will develop a multilevel 9-month culturally informed motivational interviewing and electronic messaging intervention- "Cognition After Obstructive Sleep Apnea (OSA) Among Native American People" (CATNAP) to: 1) provide participants with Motivational Interviewing sessions to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias (ADRD) in American Indians and 2) provide participants with electronic messaging to support PAP adherence among American Indian elders, aged 50 years and older.

This study will explore the relationship between OSA and cognitive function and evaluate OSA as a mechanism for the strong association between sleep disorders and Alzheimer's disease and related dementias (ADRD). CATNAP will be implemented as a randomized controlled trial at 4 community sites serving American Indians in the Northern Plains. A total of 300 American Indian elders, aged 50 years and older, with a confirmed OSA diagnosis and prescribed PAP therapy will be randomized to receive usual care consisting of PAP therapy alone (control condition) or usual care plus the culturally informed CATNAP component (intervention condition).

The primary outcome is PAP adherence and secondary outcome cognitive function. The study will partner with Missouri Breaks Industries Research Inc., and Missouri Breaks Durable Medical Equipment to monitor participants PAP use, which is uploaded automatically to the cloud. Outcomes will be measured at baseline, 3-months, and 9-months.

Eligibility criteria: Inclusion Criteria:

* Age 50 years and older
* Self report American Indian or Alaskan Native
* diagnosed with obstructive sleep apnea
* prescribed PAP therapy and have a device
* \*Ability to understand written and spoken English; and
* \*Ability and willingness to follow all study protocols.

Exclusion Criteria:

* Living in a household with someone who is enrolled in the study
* Already using PAP device at Medicaid recommended standards
* Cognitive decline, unable to consent on their own

Primary outcomes:
measure: Positive Airway Pressure (PAP) minutes per night
timeFrame: 9 months
measure: Nights of PAP use
timeFrame: 9 months
measure: PAP adherence
timeFrame: 9-months
Secondary outcomes:
measure: Montreal Cognitive Assessment total score
timeFrame: 9 months
measure: Cognivue total score
timeFrame: 9 months
Other outcomes:
Locations:
city: Eagle Butte
country: United States
facility: Missouri Breaks Industries Research Inc
state: South Dakota
Study officials:
References: