NCT07481292

Brief Summary

To investigate the feasibility of implementing an online assessment battery in tandem with normal \& customary complementary \& integrative healthcare (CIH) provided to children with dysautonomia. The secondary aim is to assess the potential impacts of CIH on clinical outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

March 4, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

March 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 4, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

DysautonomiaPilot ProjectsPediatricsComplementary Therapies

Outcome Measures

Primary Outcomes (4)

  • Proportion of enrollees who are eligible to participate

    The number of enrollees (i.e., participants who consent) who score ≥20 on the baseline Pediatric Autonomic Symptom Scales (PASS), divided by the total number of enrollees. This assesses 'Eligibility'.

    From enrollment to baseline PASS submission (up to 48-hours)

  • Proportion of participants complying with instructions

    The number of participants submitting online surveys within the 48-hour submission window, divided by the total number of participants. This assesses 'Compliance'

    From enrollment to the end of participation (up to 12 weeks)

  • Proportion of participants adhering to the care plan

    The number of participants attending ≥90% of scheduled remote sessions with their CIH practitioner, divided by the total number of participants. This assesses 'Adherence'

    From enrollment to the end of participation (up to 12 weeks)

  • Proportion of participants retained in the study

    The number of participants submitting the 4th and final online surveys, divided by the total number of participants. This assesses 'Retention'.

    From enrollment to the end of the 12 week study period

Secondary Outcomes (2)

  • Change in Pediatric Autonomic Symptom Scales (PASS) scores

    Baseline; ~4 weeks; ~8 weeks; ~12 weeks

  • Change in Short Sensory Profile (SSP) scores

    Baseline; ~4 weeks; ~8 weeks; ~12 weeks

Study Arms (1)

Children (5-12) with Dysautonomia

Children aged 5-14 years whose parents/caregivers identify the presence of symptoms associated with dysautonomia. A formal clinical diagnosis is not required for inclusion

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 5-14 years whose parents/caregivers identify the presence of symptoms associated with dysautonomia. A formal clinical diagnosis is not required for inclusion.

You may qualify if:

  • years of age
  • Baseline PASS score ≥20

You may not qualify if:

  • History of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Holistic Wellness

Madina Town, Fsisalabad, 38000, Pakistan

Location

MeSH Terms

Conditions

Autonomic Nervous System DiseasesDysautonomia like disorder

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Tyson Perez, DC, PhD

    Life University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 18, 2026

Study Start

March 14, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Deidentified IPD necessary to reproduce results

Shared Documents
ANALYTIC CODE
Time Frame
(start date): within 1 year of study completion. (end date): indefinitely
Access Criteria
IPD, metadata \& analytic code necessary to reproduce results will be made publicly accessible via a data repository
More information

Locations