Cognition After OSA Treatment Among Native American People (CATNAP)

NCT06227572 | Recruiting DMC

• 1 other identifier: P01AG066584
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Cognitive Change; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Positive Airway Pressure (PAP) minutes per night

  Participant mask-on time data collected by the PAP equipment will be extracted as continuous minutes per night.

  9 months

• Nights of PAP use

  Proportion of nights with 4+ hours of PAP use from PAP device

  9 months

• PAP adherence

  Use of device for more than 240 minutes per night, on 21 or more days out of the past 30 days. From PAP device.

  9-months

Secondary Outcomes (2)

• Montreal Cognitive Assessment total score

  9 months

• Cognivue total score

  9 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: CATNAP MI

Waitlist Control Group

NO INTERVENTION

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.

Interventions

CATNAP MI BEHAVIORAL

Three motivational interviewing (MI) sessions will be facilitated by trained MI staff and will focus on improving participants' knowledge about their OSA diagnosis, understanding of sleep health, and increasing PAP use. Sessions will also provide information about health benefits associated with good sleep and will help participants create an action plan regarding their PAP use and indicators of success, when appropriate. Electronic messaging will be standardized for frequency and content but personalized to participants' preferred mode of delivery. Messages will focus on PAP adherence or non-adherence.

Intervention Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington State University: lead
• Missouri Breaks Industries Research, Inc.: collaborator
• University of Washington: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Missouri Breaks Industries Research Inc

Eagle Butte, South Dakota, 57625, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Denise Dillard, PhD

CONTACT

206-708-8633; denise.dillard@wsu.edu

Madison B Ramos, BA

CONTACT

madison.ramos@wsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: January 29, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)