Clinical trial NCT05611814: Preliminary Evaluation of an Osteopathic Manipulative Treatment (OMT) to Prevent Motion Sickness Symptoms
Official title: Preliminary Evaluation of an Osteopathic Manipulative Treatment (OMT) to Prevent Motion Sickness Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motion Sickness
Lead sponsor: United States Army Aeromedical Research Laboratory
Sponsor class: FED
Collaborators: name: Alabama College of Osteopathic Medicine
name: Department of Aviation Medicine, U.S. Army Medical Center of Excellence
First posted: 2022-11-10
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between subjects design with two groups: sham and experimental (osteopathic manipulative treatment \[OMT\])
Primary purpose: PREVENTION

Brief summary: Motion sickness directly impacts the readiness of the Army's aviation units. Severe motion sickness results in the dismissal of pilot and air crew candidates during initial training, while minor to moderate symptoms can be distracting during flight. The current medications on the market that target motion sickness symptoms are prohibited for use before flight. Osteopathic Manipulative Techniques are a low to no cost option, which lacks side effects, that allows Doctor of Osteopathic Medicine flight surgeons the opportunity to treat crew members without the use of pharmaceuticals. If effective, these techniques could be used to ensure aircrew readiness. Given the paucity of research on such a technique, a small, pilot study was conducted to demonstrate potential for such an approach.


Eligibility criteria: Inclusion Criteria:

* Must have normal hearing, vision or corrected to normal vision, and cognitive function as determined by self-report and review on demographics and personal history questionnaire.
* Must have obtained at minimum 6 hours of sleep prior to data collection, as assessed by self-report.
* Must have refrained from consumption of alcohol and Medications that impact motion sickness symptoms for a minimum of 16 hours prior to each test session, assessed by self-report.

Exclusion Criteria:

1. Must not be currently taking any medications that may affect the vestibular system as assessed by self-report and at the discretion of the study physician.
2. Must not have a history of vestibular disorders as assessed by self-report.

Primary outcomes:
measure: Change in Motion sickness assessment questionnaire: gastrointestinal subscore from pre- to post-procedure
timeFrame: Administered immediately pre and post-procedure
measure: Change in Motion sickness assessment questionnaire: central subscore from pre- to post-procedure
timeFrame: Administered immediately pre and post-procedure
measure: Change in Motion sickness assessment questionnaire: peripheral subscore from pre- to post-procedure
timeFrame: Administered immediately pre and post-procedure
measure: Change in Motion sickness assessment questionnaire: sopite-related subscore from pre- to post-procedure
timeFrame: Administered immediately pre and post-procedure
measure: Change in Motion sickness assessment questionnaire: total subscore from pre- to post-procedure
timeFrame: Administered immediately pre and post-procedure
measure: Heart rate variability
timeFrame: Measured throughout procedure (10 minutes total)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Rucker
country: United States
facility: US Army Aeromedical Research Laboratory
state: Alabama
Study officials:
References: