ACTIVE_NOT_RECRUITING

Auricular Acupuncture for Sleep Disturbances

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

A randomized controlled trial of auricular acupuncture for sleep disturbances. * Objective 1: Evaluate the effectiveness of a specific protocol of auricular acupuncture in the treatment of sleep disturbance among active duty and otherDoD beneficiaries. * Objective 2: Test whether a brief course of auricular acupuncture treatments among active duty and other DoD beneficiaries with sleep disturbance willalso decrease severity of anxiety, depression, pain and improve sleep and social functioning in subgroup analysis of subjects with known or newlydiagnosed mental health disorders (e.g., anxiety disorders, depression). * Null Hypothesis: Auricular Acupuncture has no effect on sleep disturbance. * Alternative Hypothesis: Auricular Acupuncture reduces sleep disturbance.

Official Title

Auricular Acupuncture for Sleep Disturbances: A Randomized Control Trial

Quick Facts

Study Start:2022-05-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04956341

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female Active Duty members and DoD beneficiaries ages 18-80 with complaints of sleep disturbances.
  2. * PROMIS-16 Sleep-Related Impairment Scale with a score of medium or severe (T-Score greater than or equal to 60).
  1. * Patients with OSA who are prescribed CPAP/BiPAP and either do not use it or use it \<70% of time per patient report.
  2. * Investigators seek to exclude individuals with sleep-related medical or psychiatric conditions that are so severe as to render these patients inappropriate for treatment in primary care or simple mental health without psychiatry oversight or that acupuncture cannot be expected to have an effect on (e.g., thyroid disease). Specifically, exclusion criteria will include:
  3. * Psychosis
  4. * Thyroid disease undergoing active adjustment of medication.Depression, with suicidality. (clinician judgment)
  5. * Greater than 10 mg equivalent of diazepam equivalent per day for any reason
  6. * Non-response to greater than 2 PSTD treatments
  7. * Having acupuncture not related to sleep in the past 3 months
  8. * Pregnant

Contacts and Locations

Principal Investigator

Paul Crawford, MD
PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences

Study Locations (Sites)

Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191
United States

Collaborators and Investigators

Sponsor: Paul Crawford

  • Paul Crawford, MD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences

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 Date2022-05-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-05-01
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • acupuncture
  • auricular acupuncture
  • sleep

Additional Relevant MeSH Terms

  • Sleep Disturbance