Cognition After OSA Treatment Among Native American People (CATNAP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CATNAP MI.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea, Cognitive Change. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cognition After Obstructive Sleep Apnea (OSA) Treatment Among Native American People (CATNAP)
Overview
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.
Interventions
- Behavioral CATNAP MI
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 p
Primary outcome measures
- Positive Airway Pressure (PAP) minutes per night [Time frame: 9 months]
- Nights of PAP use [Time frame: 9 months]
- PAP adherence [Time frame: 9-months]
Secondary outcome measures (2)
- Montreal Cognitive Assessment total score [Time frame: 9 months]
- Cognivue total score [Time frame: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Missouri Breaks Industries Research Inc — Eagle Butte
Identifiers
NCT: NCT06227572 · P01AG066584