Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-24

Study Completion Date

2023-12-15

Brief Summary

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An observational study to determine outcomes of older adults who are under naturopathic medical care for cognitive complaints at a specific clinic in Southern California.

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Detailed Description

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This prospective observational study will examine patient outcomes associated with individualized, whole-system integrative medical care, provided by a naturopathic physician at a specific clinic in the state of California. Participants will be older adult patients of the clinic who present with objectively measurable cognitive dysfunction, and who elect to voluntarily participate in the study.

Participants' cognitive function will be assessed using validated objective (NIH Toolbox) and subjective (NIH Neuro-Quality of Life questionnaires) instruments. The primary outcomes are change from baseline to six months post-baseline in these two instruments.

Additionally, physical activity and sleep data will be tracked using wearable telemetry, and neurophysiological parameters will be measured with electroencephalography. Detailed treatment descriptions and adverse events will be tracked.

Conditions

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Cognitive Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Enrolled Participants

This is a whole-practice precision medicine model in which a participant-specific Naturopathic treatment program is developed and implemented for older adults with cognitive complaints.

Whole-practice cognitive optimization

Intervention Type OTHER

This intervention is a whole-practice intervention that may include nutritional assessment \& supplementation, determination of food sensitivities and dietary changes, natural products such as herbal anti-inflammatories, assessment of whole body-burden of toxicants (such as heavy metals and fungal toxins) and steps to reduce exposures, and behavioral changes such as exercise, meditation, and sleep hygiene optimization.

Interventions

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Whole-practice cognitive optimization

This intervention is a whole-practice intervention that may include nutritional assessment \& supplementation, determination of food sensitivities and dietary changes, natural products such as herbal anti-inflammatories, assessment of whole body-burden of toxicants (such as heavy metals and fungal toxins) and steps to reduce exposures, and behavioral changes such as exercise, meditation, and sleep hygiene optimization.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Community-dwelling adults ≥60 years of age.
* Montreal Cognitive Assessment (MoCA) score of 12-23.
* Able to independently make decisions.
* Able to safely travel to North County Natural Medicine for 4 study visits and approximately 4 clinical visits, for a duration of 6 months.
* Able to wear an Oura Ring, download data every 6 days, and keep the ring regularly charged for the duration of participants' involvement in the study.
* A high school diploma or equivalent.
* Ability to communicate via email.
* Ability to independently fill out a computer-administered questionnaire.
* Ability to withhold from seeing another integrative or alternative medicine provider for the 6 months of participation in the study.

Exclusion Criteria

* Inability to read and write in English.
* MoCA score \>23.
* A visual impairment that would prevent reading a computer screen.
* Partial or full deafness.
* A previous diagnosis of dementia (e.g. Alzheimer's Disease or any other kind of dementia).
* Congenital cognitive impairment or disability.
* Alcohol or substance abuse.
* Serious somatic disease, neurodegenerative disease, acute onset of cognitive decline, or rapid neurological impairment.
* Inability to bring an affiliate to the Informed Consent Consultation.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes