The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 2
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients With Decreased Respiratory Function. Study 2: Children With Cystic Fibrosis for Long Term Evaluation
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with Decreased Respiratory Function is a proposal for investigation of the application of gaming to improving respiratory health. The Jamboxx device combines gaming with traditional incentive spirometry to provide users with a fun experience to keep them engaged in their respiratory therapy routine. The device allows users to play a series of mini-games that walk them through their routines. The Jamboxx also records airflow and lung parameters with an external mouthpiece attachment to provide users with real time feedback, and helps to assess increases or decreases in relative lung function over time. The Jamboxx has the potential to significantly impact the field of respiratory therapy by being one of the first gaming devices for patient therapy, and the first respiratory therapy gaming device that is accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost alternative to the traditional therapy techniques used and aims to improve patient compliance.
This study addresses the ongoing challenge of clearing the burden of bronchial secretions resulting from cystic fibrosis. These patients are dependent upon mechanical devices to help clear secretions. A device autonomous means for clearing secretions is well defined in the literature (autogenic drainage) but is difficult to learn. This study proposes to teach cystic fibrosis patients to master autogenic drainage, and seeks to determine at what age it can be taught. As it would be expected that gaming could easily teach adults this procedure, the study will include children for whom learning autogenic drainage based upon conceptualization would be expected to be very difficult.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Testing Plan: Children will be randomized into one of two groups via a random number generation software program
Group A (education & gaming): Children will participate in 1 initial training session at Albany Med where they will be taught by a respiratory therapist (RT) to use autogenic drainage: a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to practice the autogenic draining technique 15 minutes three times per week. At week 8 +/- 1 week patients will return for study visits and will be tested by a software program designed to evaluate their ability to perform autogenic drainage sequence (percent accuracy). This will be done through a software program installed on the device that uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a percent accuracy. At the 8 week visit, the Jamboxx gaming device will be introduced through a training session with a RT, which will contain a game to guide them through the proper sequence of breathing for the autogenic draining technique. Patients will be sent home with a Jamboxx device and requested to do 15 minutes of autogenic drainage training three times a week. Patients will return for a research visits at week 16 and again will be tested via software program for ability to perform the autogenic drainage technique.
Group B (gaming only): Children will participate in an initial training session at Albany Med where they will be taught by a RT to use Jamboxx respiratory thearpy device to guide them through autogenic drainage: a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to use the Jamboxx respiratory therapy device 15 minutes three times per week. At week 8 and week 16 +/- 1 week patients will return for study visits and will be tested by a software program designed to evaluate their ability to perform autogenic drainage sequence (percent accuracy). This will be done through a software program installed on the device that uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a percent accuracy.
This protocol does not replace prescribed chest physiotherapy. There is no alteration of the standard of care beyond 15 minutes of autogenic drainage three times per week. Demographic data (age, gender, ethnicity) will be collected. Medical records will be evaluated for relevant health history, medication use, and hospitalizations including dates.
Typ studie
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
New York
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Albany, New York, Spojené státy, 12208
- Albany Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Children with CF requiring chest physiotherapy ages 5-17
Exclusion Criteria:
- Children with lung function of <25% FEV, hypercapnia, or requiring supplemental oxygen will be excluded.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Group A: Education & Gaming
Children will participate in 1 initial training session where they will be taught by a RT to use autogenic drainage (AD).
Patients will be sent home & prescribed to practice the technique 15 minutes 3 times / week.
At week 8 +/- 1 week patients will return and will be tested by a software program designed to evaluate their ability to perform the AD sequence (percent accuracy).
At the 8 week visit, the Jamboxx gaming device will be introduced, which will contain a game to guide them through the proper sequence of breathing for the AD technique.
Patients will be sent home with a Jamboxx device and requested to do 15 minutes of AD training 3 times / week.
Patients will return at week 16 and again will be tested via software program for ability to perform the AD technique.
|
The Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines.
The device consists of a computer game controller with mouthpiece, and breath flow sensor that connects to a tablet.
With the Jamboxx respiratory therapy device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.
A respiratory therapist will teach children how to conduct the autogenic draining technique (a series of exhalations and inhalations) by demonstrating the technique to them, and having them practice in their office.
Children will also receive an informational packet and short video about the technique for reference
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Experimentální: Group B: Gaming Only
Children will participate in an initial training session at Albany Med where they will be taught by a RT to use the Jamboxx respiratory therapy device to guide them through autogenic drainage (AD): a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways.
Patients will be sent home and prescribed to use the Jamboxx respiratory therapy device 15 minutes three times per week.
At week 8 and week 16 +/- 1 week patients will return and will be tested by a software program designed to evaluate their ability to perform AD sequence (percent accuracy).
|
The Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines.
The device consists of a computer game controller with mouthpiece, and breath flow sensor that connects to a tablet.
With the Jamboxx respiratory therapy device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in accuracy with the autogenic draining technique
Časové okno: Weeks 0, 8, 16
|
A software program has been developed by the study team to evaluate ability to perform autogenic drainage sequence (percent accuracy).
This program will be installed on the Jamboxx Respiratory Therapy device (without the associated games), and uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a change in percent accuracy from the baseline value to the end of the 16 week study.
|
Weeks 0, 8, 16
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cystic Fibrosis Questionnaire- Revised
Časové okno: Weeks 0, 16
|
A study developed by the Cystic Fibrosis Foundation to evaluate respiratory function and overall health and wellbeing for children living with CF
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Weeks 0, 16
|
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Clinically relevant events & exacerbations
Časové okno: Weeks 0, 8, 16
|
e.g.
patient being sent for a chest x-ray, being ordered chest physiotherapy, prescribed to new systemic antibiotics, hospital admission
|
Weeks 0, 8, 16
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Marilyn Fisher, MD, Albany Medical Center IRB
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Jamboxx RT Device Study 2
- 4R42HL132735-02 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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