Cognition After OSA Treatment Among Native American People (CATNAP)

Washington State University

Status: Enrolling

Conditions: Cognitive Change; Obstructive Sleep Apnea

Treatments: Behavioral: CATNAP MI

Study type: Interventional

Funder types: Other

Identifiers

NCT06227572

P01AG066584

Details and patient eligibility

About

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).

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The CATNAP MI intervention consists of 3 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 electronic messaging to support PAP adherence, and usual care. Data will be collected at baseline, 3-months, and 9-months.

Treatment:

Behavioral: CATNAP MI

Waitlist Control Group

No Intervention group

Description:

Usual care, consisting of an in-service on how to operate the PAP machine, and a mask fitting to select the most comfortable, effective mask for the individual. After 4-6 weeks of use, the participant will be contacted by Missouri Breaks Durable Medical Equipment to review objective adherence data and address any challenges or barriers to therapy such as treatment-emergent central apneas. Data will be collected at baseline, 3-months, and 9-months.