ssNPA for Children, Only

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
C.S. Mott Children's Hospital, Ann Arbor, MI
Children, Only+4 More
ssNPA - Device
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia

See full description

Eligible Conditions

  • Children, Only
  • Hypotonia
  • Sleep Apnea, Obstructive

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Children, Only

Study Objectives

This trial is evaluating whether ssNPA will improve 3 primary outcomes and 5 secondary outcomes in patients with Children, Only. Measurement will happen over the course of 8 weeks.

8 weeks
Ability to tolerate
Comfort
Daytime sleepiness
Device design
Ease of use
Insertion protocol
Sleep quality
Snoring

Trial Safety

Safety Progress

1 of 3

Other trials for Children, Only

Trial Design

1 Treatment Group

ssNPA
1 of 1
Experimental Treatment

This trial requires 5 total participants across 1 different treatment group

This trial involves a single treatment. SsNPA 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.

ssNPA
Device
self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 weeks for reporting.

Who is running the study

Principal Investigator
D. Z.
Prof. David Zopf, Assistant Professor of Otolaryngology-Head and Neck Surgery
University of Michigan

Closest Location

C.S. Mott Children's Hospital - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Children, Only or one of the other 4 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
hypotonia
obstructive sleep apnea on polysomnogram with AHI>=10
presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)

Patient Q&A Section

How many people get floppy muscles a year in the United States?

"About 70 million Americans have floppy muscles, making it the most common body shape problem in boys and the fourth most common in adults in the Unites States." - Anonymous Online Contributor

Unverified Answer

Can floppy muscles be cured?

"This paper explains how we are using the results of magnetic resonance imaging to show how the floppy muscle can be cured. We used the term 'hypercontractibility', but we should now use 'floppy' muscles to describe the muscle, as the muscles are not contracting for reasons other than a lack of contraction, i.e. they are 'floppy' and not being'stiff'." - Anonymous Online Contributor

Unverified Answer

What is floppy muscles?

"Floppy muscles are not as stiff as skeletal muscle fibers, yet they contract in a similar way. In contrast to the sarcomeres in skeletal muscle, the proteins that make up the A-band in fibrofatty tissues don't form a regular packing. The protein that binds to the Z-lines is a different protein than what binds to the A bands in skeletal muscle. However, the basic building blocks for muscle proteins and collagen are very similar. These similarities suggest that floppy muscles may be able to contract in a similar way as skeletal muscles." - Anonymous Online Contributor

Unverified Answer

What causes floppy muscles?

"A predisposition for abnormal physiology, such as floppy muscles, is an important feature affecting many people and families. The mechanism for this abnormality is not understood, but the symptoms are well known and can have a disabling impact on quality of life." - Anonymous Online Contributor

Unverified Answer

What are the signs of floppy muscles?

"Floppy muscles that do not do their job well are not always associated with skeletal muscle disease. However, when floppy muscles are associated with a skeletal muscle disease, the diagnosis of skeletal muscle disease should be considered. It appears that most commonly encountered patients whose floppy muscles do not work well have an increased prevalence of skeletal muscle disease. Further research would help us understand the mechanisms behind floppy muscles and hopefully decrease the prevalence of floppy muscles and improve muscle function." - Anonymous Online Contributor

Unverified Answer

What are common treatments for floppy muscles?

"No single course of treatment will correct floppy muscles for everyone; therefore treatment should be customized specifically for each person to limit discomfort caused by the condition. Surgical treatment may be necessary in some cases of spasticity and/or tightness." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of floppy muscles?

"Individuals with floppy muscles have a higher muscle tone and have a higher body mass index. The latter could be a result of poor exercise habits or a failure to recover from an illness (such as hypoglycemia) and can make it difficult to perform physical activities, especially when walking. If you are experiencing the symptoms of floppy muscles, make sure your caloric intake is adequate. The following are additional ways in which you can improve your strength and endurance. First, if you are experiencing stiffness in certain muscles, take it easy and practice stretching. To prevent injury, keep your muscles hot and fit." - Anonymous Online Contributor

Unverified Answer

Does floppy muscles run in families?

"The prevalence of FLP in the siblings of symptomatic and asymptomatic females is greater than expected because of the possibility of the occurrence of a genetic modifier of the phenotype. This result emphasizes the need for further studies employing clinical and genetic characterization of these patients to obtain information regarding disease prognosis and possible new treatments." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets floppy muscles?

"The most common symptom of floppy paralysis of the adductor pollicis brevis muscle (i.e. "floppy muscles") in the arm is weakness or numbness in the thumb (95%). The second most common symptom is the "pump out" phenomenon of the adductor pollicis muscle (94%). In the leg, the most common symptom is the inability to lift the foot and toes from the floor (91%). Also, 93% of the subjects reported tenderness." - Anonymous Online Contributor

Unverified Answer

What is ssnpa?

"[SSNPA (scleroderma, scleromyositis and polyarthritis (SSc) overlap syndrome; also known as SSc-SSc overlap syndrome or SSc-rheumatoid arthritis overlap syndrome) is a rare subtype of systemic sclerosis. Rarely, patients have rheumatoid arthritis, Sjögren's syndrome, or systemic lupus erythematosus, which can develop with or without SSc. These disorders can be difficult to distinguish from primary systemic sclerosis, and treatment with glucocorticoids has been reported to suppress scleroderma but worsen other disorders, such as rheumatoid arthritis and scleroderma-associated lung disease." - Anonymous Online Contributor

Unverified Answer

How serious can floppy muscles be?

"A small change in muscle quality in a highly active man could trigger a series of muscle diseases called muscle dysfunctions that could be life threatening. If you have flappy muscles in your back, make sure you get [physical therapy] (https://www.physiatry.com/medical/muscles/exercise_in.php) to help restore and maintain a healthy amount of muscle. As a rule of thumb, check the physical therapist before proceeding." - Anonymous Online Contributor

Unverified Answer

What is the latest research for floppy muscles?

"The most frequent etiologies of floppy muscles are trauma, metabolic issues, and muscular dystrophy (i.e., Duchenne muscular dystrophy, Becker muscular dystrophy and muscular dystrophy with respiratory involvement). Other causes may include myotonic dystrophy, muscular dystrophy (i.e., Emery-Dreifuss muscular dystrophy and limb girdle muscular dystrophy) and spinal muscular atrophy. The prognosis, as it differs by etiology, is related to the severity of the muscle involvement and is most likely determined by a patient's age, the severity of exercise, and the number of muscles affected." - 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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