Book reading for Segmental Autonomic Dysfunction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tulane University Lakeside Hospital, New Orleans, LA
Segmental Autonomic Dysfunction+2 More
Book reading - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether live reading can improve the autonomic nervous system of the mother and the newborn.

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Eligible Conditions

  • Segmental Autonomic Dysfunction

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Book reading will improve 2 primary outcomes in patients with Segmental Autonomic Dysfunction. Measurement will happen over the course of 20 minutes of reading.

20 minutes of reading
Determine the change in parasympathetic nervous system response
Determine the change in vagal tone

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Patient arm
1 of 1
Experimental Treatment

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. Book Reading is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Patient arm
Behavioral
The subject population will be newborn infants admitted to the Newborn Nursery (NN) at Tulane Lakeside Hospital. The investigators are anticipating some mothers can be recruited from the prenatal clinics who expect to deliver at Tulane Hospital during pregnancy as well.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 minutes of reading
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 20 minutes of reading for reporting.

Closest Location

Tulane University Lakeside Hospital - New Orleans, LA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Admitted to the Tulane-Lakeside Hospital Newborn Nursery
Corrected gestational age 34 weeks or older
No identified hearing disorder
Do not have a diagnosed developmental disability (i.e. Down Syndrome)
Do not have Fetal Alcohol Syndrome
Medically cleared to participate in the study
Biological mother able/willing to give consent in English & complete surveys.

Patient Q&A Section

How many people get segmental autonomic dysfunction a year in the United States?

"Segmental autonomic dysfunction occurs in a majority of adults, underscoring its importance as a predictor of death. Segmental autonomic dysfunction is seen more often in patients with diabetes and a higher rate of co-morbid conditions. In addition to autonomic assessment, physicians should consider counseling patients about the risk associated with smoking cessation, cardiovascular disease and death as well as lifestyle modification to decrease the risk of developing an autonomic disorder." - Anonymous Online Contributor

Unverified Answer

What are the signs of segmental autonomic dysfunction?

"Segmental autonomic dysfunction presents with symptoms of orthostatic hypotension, absent or decreased sweating, absent or decreased perspiration, and decreased or absent sweating following heat stress." - Anonymous Online Contributor

Unverified Answer

What is segmental autonomic dysfunction?

"The present report provides support for the view that there is a high prevalence of autonomic neuropathy in patients with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes), even before the onset of microalbuminuria. In this group, there is a more rapid development of cardiorespiratory autonomic neuropathy than previously reported in patients with type 1 or type 3 diabetes." - Anonymous Online Contributor

Unverified Answer

What are common treatments for segmental autonomic dysfunction?

"Common treatments include: pharmacological therapy and surgical correction. Pharmacological therapy typically involves the use of beta blockers, anti-diabetics, anticholinergics, or an alpha1 antagonist. Although the exact therapeutic efficacy of pharmacological therapy is unknown, most patients recover quickly and have little negative side effect." - Anonymous Online Contributor

Unverified Answer

What causes segmental autonomic dysfunction?

"Segmental autonomic dysfunction is a non-specific sign of autonomic neuropathy. The underlying mechanisms are largely unknown. The high prevalence of segmented dysfunction in subjects with ICDs and diabetes should prompt further research that could yield the means to identify an underlying neural cause for each of these syndromes." - Anonymous Online Contributor

Unverified Answer

Can segmental autonomic dysfunction be cured?

"Segmental autonomic dysfunction is unlikely to be cured or fully reversed by conventional rehabilitation, but a large number of patients claim that they feel better. Further studies are now needed to confirm the extent to which patients are exaggerating their functional deficit." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of segmental autonomic dysfunction?

"Segmental sympathetic failure can result from a variety of causes that are best treated with symptomatic therapy. In patients with refractory vasomotor symptoms, the causes of segmental autonomic dysfunction may be a primary disorder of the sympathetic efferent fibers, resulting in secondary compensatory hyperactivity of the hypothalamic-pituitary-adrenal axis; an alteration of the normal parasympathetic balance of sympathetic activity; and/or the failure of the normal somatic autoregulatory pathways." - Anonymous Online Contributor

Unverified Answer

Does book reading improve quality of life for those with segmental autonomic dysfunction?

"Improved health-related functioning persists for participants as well as their family caregivers for up to 12 weeks, although they are not at the optimal level at this point. Improved HRQOL also correlates with increased book reading. There was higher engagement in book reading with an increase in HRQOL. This intervention is likely a viable option for people with SD." - Anonymous Online Contributor

Unverified Answer

Does segmental autonomic dysfunction run in families?

"Results from a recent paper suggest that the SDG is associated with the HLA DR allele and that DR15/16 may act as a marker for the familial subtype of SDG. Segmental SDG is a genetic subtype of SDG that is distinct from typical SDG, a disorder that lacks a familial risk factor." - Anonymous Online Contributor

Unverified Answer

What is the latest research for segmental autonomic dysfunction?

"Recent findings of this article are relevant in understanding the causes and mechanisms for autonomic dysfunction. Research methods can make it easier to clarify what may be the causes of the autonomic dysfunction, to identify and refine the mechanisms of autonomic dysfunctions, and to identify the effective therapeutic target groups." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in book reading for therapeutic use?

"This paper discusses the latest developments with book reading as an intervention for stress-related and anxiety disorders, posttraumatic stress and adjustment to traumatic events, chronic conditions or physical diseases. The findings of this paper will help encourage book reading and book reading researchers to develop a research agenda that will contribute more to the evidence base of book reading interventions on the effectiveness of book reading in everyday life." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for segmental autonomic dysfunction?

"Segmental autonomic dysfunction (SDD) is a common clinical phenomenon of PD in patients whose predominant parkinsonian symptoms are not well responsive to dopamine replacements. Therefore, it is crucial to identify PD patients who are likely to show SDD in their course. Patients with early PD who are responsive to dopaminergic replacement and with moderate disease complexity may be the most suitable candidates for such clinical trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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