3D printed NIV mask for Apnea

Phase-Based Estimates
1
Effectiveness
1
Safety
Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Apnea+3 More
3D printed NIV mask - Device
Eligibility
< 65
All Sexes
Eligible conditions
Apnea

Study Summary

This study is evaluating whether a customized sleep mask may help improve sleep apnea.

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Eligible Conditions

  • Apnea
  • Sleep Apnea Syndromes
  • Sleep Apnea
  • Pediatric Sleep Apnea

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 3D printed NIV mask will improve 1 primary outcome in patients with Apnea. Measurement will happen over the course of 6 months.

6 months
Adherence Rate

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
3D Printed NIV Mask

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. 3D Printed NIV Mask 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.

3D Printed NIV Mask
Device
3D imaging and use of a custom mask from 3D printer
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Cincinnati Children's Hospital Medical Center - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
On stable NIV settings for a minimum of 2 months.

Patient Q&A Section

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

How many people get apnea a year in the United States?

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Almost half of American adults over the age of 65 have apnea and this is increasing. This would be the first study of its kind which indicates a nationwide rise in the proportion of older people having apnoea when compared to previous studies.

Unverified Answer

What are the signs of apnea?

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The signs of apnea are short bouts of labored breathing and gasping. The child can show signs such as fatigue, red eyes, or drooling. The child might breathe deeply during such a symptom. Parents should be alert to this problem. If a seizure is suspected, it should be evaluated with a child in a supine position for a short period.\n

Unverified Answer

What is apnea?

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Apnea is the interruption of normal breathing while the person is not conscious. It may be caused by a number of factors such as anesthesia, medication, and disease processes. Most commonly, an interruption in the normal respiration pattern is associated with sleep apnea. Apnea can cause significant harm during the operation, such as hypoxia (low levels of oxygen in the blood) and arrhythmias (abnormal heart rhythms). The most common complaint about the apnea event during an operation is choking or choking-like sensations that cause discomfort toward the end of the operation. The most common respiratory event is a sigh at the end of the operation.

Unverified Answer

What are common treatments for apnea?

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Apnea is commonly treated with nasal continuous positive airway pressure (pi-PAP, nCPAP) and mechanical ventilation. Tracheal intubation is recommended for patients who require non-invasive mechanical ventilation for long periods of time or for patients for whom nCPAP and mechanical ventilation are contraindicated.

Unverified Answer

What causes apnea?

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A variety of conditions can cause apnea, which in itself can be a cause of many disorders. The mechanisms of sleep apnea can be complex and may include problems with brainstem regulation of respiration. Sleep apnea is also increasingly recognized to be associated with a range of cardio-respiratory diseases.

Unverified Answer

Can apnea be cured?

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In a carefully selected patient population and during appropriate treatment, apnea is a fairly common respiratory symptom. Most of the patients have no significant respiratory compromise despite having the disease. A diagnosis of apnea is made frequently in patients that have a respiratory evaluation during the course of an outpatient visit, particularly those with unexplained symptoms of fatigue and chest pain. When these patients are evaluated by a respiratory center, a comprehensive respiratory evaluation, with careful history and careful physical examination can identify those with severe respiratory compromise who can be evaluated by a respiratory specialist. In these patients, apneas can be treated, usually with oxygen therapy. When these patients return in the primary care setting for some reason, most of the time they are asymptomatic to a remarkable extent.

Unverified Answer

What is the latest research for apnea?

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Apnea is a very common problem in the NICU. It is estimated that 1 in 5 of the newborns present with an apnea at the time of discharge or during their first hospital stay. It is also an important health concern, as it can result in serious and potentially life-threatening complications for the hospitalized infants; thus, the treatment of apnea should be carefully studied. A recent randomized, double-blind, placebo-controlled trial showed that continuous positive airway pressure (CPAP) significantly improves oxygenation in preterm infants at high risk of apneas. The use of CPAP decreased the number of apneas as well as the number of associated symptoms, in most cases without an increase in the need for medical interventions.

Unverified Answer

How serious can apnea be?

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In severe disease and in the absence of a good history, the absence of nocturnal hypothermia or respiratory rate of less than 60 beats per minute, and of chest compression in more than two instances warrants an assessment for the presence of pulmonary emboli. The presence of jugular vein dilatation and hepatic abnormalities suggests that thromboembolism may be occurring and treatment with direct-acting oral anticoagulants is indicated.

Unverified Answer

Who should consider clinical trials for apnea?

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[Those who] are under the age of 18, on long-term supplemental oxygen, who meet other clinical trial entry criteria, or who are in a hospice facility or have a life support device may be eligible to participate in clinical trials; however, [no] one group should be considered as representative of all people with obstructive sleep apnea syndrome.

Unverified Answer

What is 3d printed niv mask?

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There are many advantages to patients using their masks. The most important advantage is comfort of using a 3d printed mask for an 8-10 hour sleep/wake cycle. Secondly, the convenience of wearing and removing and cleaning the mask at home is a big plus. Third, there are many advantages to using a mask to relieve obstructive sleep apnea. We can be more comfortable when sleeping at home because there is a decreased need for the patient to be at home to sleep at home with an apnea belt on. Fourth, many patients with sleep apnea are advised to wear masks to sleep, but it is very complicated to get and wear them.

Unverified Answer

What is the primary cause of apnea?

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apnea most frequently results from airway obstruction or the inability of a muscle relaxant to achieve apnea. A minority of apneas results from primary airway or respiratory muscle disease. The primary cause of apnea is multifactorial and can be difficult to discern from airway obstruction alone.

Unverified Answer

Does apnea run in families?

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The present study provides, to our knowledge, the first evidence of a familial risk of apnea in the general population. Moreover, this study has the additional disadvantage of a lower power to evaluate the association between apnea and mortality, as in siblings.

Unverified Answer
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