RECRUITING

Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

More than 15 million family caregivers provide support for individuals with Alzheimer's disease (AD) or related dementias. This number is expected to grow with the increasing population of persons with dementia (PWD). Stress in caregivers to older adults with chronic diseases is already a significant public health issue because it is associated with multiple negative physical and mental health outcomes for the caregiver (e.g., depression, cardiovascular disease) and can negatively impact the health of the PWD as well. Importantly, stress levels are even higher in female than male caregivers and in caregivers to PWD than other chronic conditions that affect older adults. There are numerous interventions to improve well-being in caregivers to PWD, but only two have been shown to moderately improve caregiver depression and quality of life in the PWD. However, both of the interventions are time and energy intensive. One promising candidate to reduce stress and improve quality of life is the endogenous neuropeptide oxytocin (OXT). Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline personality disorder, Post-traumatic Stress Disorder (PTSD), Anxiety Disorder, and Depressive Disorder. This study will assess the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to PWD. Participants will be randomly enrolled to one of three groups: 12 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo. The study drug will be administered daily for 21 days.

Official Title

Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Quick Facts

Study Start:2025-07-28
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06364228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Females 50 years of age or older
  2. * Currently an unpaid family caregiver to an older adult (50 years and older) with dementia for at least five hours a week for at least six months
  3. * Normal or corrected to normal vision and hearing
  4. * Mobility to travel to University of Nebraska Medical Center (UNMC) for study procedures including brain imaging
  5. * Right-handed
  6. * Capacity to read and write English
  1. * Major medical illness that contraindicates oxytocin (OXT) administration (e.g., severe liver disease, seizure disorder, metabolic disorder)
  2. * History of allergic reaction to oxytocin (OXT) and its nasal spray product
  3. * History of central nervous system (CNS) disease, including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis
  4. * Currently pregnant or planning to become pregnant during the course of the study
  5. * Metal in the body (i.e., hearing aid, cardiac pacemaker, bone plates, braces, non-removable piercing/implants, etc.), claustrophobia, or any other condition that would preclude magnetic resonance imaging (MRI) scanning
  6. * Mini-mental status exam score of 25 or lower which suggests possible cognitive issues
  7. * History of or current neurological disease (e.g., stroke, traumatic brain injury, brain tumor, dementia)
  8. * History of or current severe psychiatric disease (e.g., schizophrenia, bipolar disorder, autism, severe post-traumatic stress disorder)
  9. * History of, or current drug or alcohol abuse
  10. * Currently breastfeeding
  11. * Current coronavirus disease-19 (COVID-19) illness
  12. * Left-handed due to brain structural difference between right and left-handed individuals
  13. * Currently taking antipsychotic medications, selective serotonin reuptake inhibitors (SSRIs) or corticosteroid creams/pills

Contacts and Locations

Study Contact

Soonjo Hwang, MD
CONTACT
402-552-6351
soonjo.hwang@unmc.edu
Minjoo Kang, MEd
CONTACT
402-552-6239
mkang@unmc.edu

Principal Investigator

Soonjo Hwang, MD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

University of Nebraska Medical Center, Department of Psychiatry
Omaha, Nebraska, 61898-5581
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Soonjo Hwang, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-28
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-07-28
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Oxytocin
  • Stress level
  • Caregivers
  • Dementia
  • fMRI
  • Neuroimaging
  • Quality of Life

Additional Relevant MeSH Terms

  • Stress