CClinicalTrials.gg
CompletedNCT02500030Updated Jul 16, 2015

Air Stacking vs Glossopharyngeal Breathing in Neuromuscular Diseases

An interventional study of Glossopharyngeal Breathing and Air Stacking in Neuromuscular Diseases, sponsored by University of Chile. Completed. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2015-07-16.

Sponsored by University of Chile · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study summary

Neuromuscular diseases (NMD) are characterized by a reduced maximum insufflation capacity (MIC), which contributes to increased morbidity and mortality from respiratory diseases. Techniques such as glossopharyngeal breathing (GPB) and insufflation using a manual resuscitation bag, or "air stacking (AS)", can be used to increase the MIC. These techniques employ different mechanisms, and the ability to learn the technique plays a key role in its proper implementation and effectiveness. The objective is compare the effects of AS and GPB on the MIC in patients with NMD.

Children and adolescents with NMD who were users of non-invasive mechanical ventilation were recruited. Vital capacity (VC) and MIC were measured prior to and after the intervention with AS and GPB. Values were compared pre- and post-intervention and were considered statistically significant if p \<0.05.

Read the detailed description

In neuromuscular diseases (NMD), progressive weakness of the respiratory muscles causes changes in the cough mechanism and prevents the elimination of secretions, which is the main cause of morbidity and mortality in this population.

Improving the cough response and achieving effective secretion elimination is required to increase lung volume and optimize the peak cough flow (PCF). It has been shown that a high PCF decreases respiratory complications in NMD. Vital capacity (VC) and maximum insufflation capacity (MIC) are the most important factors in increasing the PCF and, consequently, obtaining a more effective cough; thus, optimizing the lung volumes to achieve an adequate cough flow is important for effective bronchial hygiene. Currently, manual techniques are used to increase the MIC to achieve an effective PCF.

The most important manual techniques used to improve the MIC and, consequently the PCF, are air stacking (AS) and glossopharyngeal breathing (GPB). These have the advantages of low cost, patient autonomy and relative ease of learning compared to other techniques using electromechanical devices (e.g., volumetric ventilators and mechanical cough assist devices), whose main disadvantages are the high cost and complexity of use. AS involves delivering multiple breaths into a manual resuscitation bag and holding the insufflation volumes with the momentary closure of the glottis, which is repeated until the MIC is reached. GPB uses the glossopharyngeal muscles to successively introduce small amounts of air into the lungs to induce coughing and assist the weak inspiratory muscles. These techniques have been useful in treating different NMD, such as Spinal Muscular Atrophy (SMA) Type II, Duchenne Muscular Dystrophy (DMD) and Spinal Cord Injury (SCI).

The aim of this study was to compare the effects of two low-cost techniques, AS and GPB, on the MIC in children and adolescents with NMD. The hypothesis of this investigation was that although both techniques are effective, using AS results in a higher MIC than GPB.

02

Conditions studied

  • Neuromuscular Diseases
03

In context

Neuromuscular Diseases

300 studies on the registry are indexed under Neuromuscular Diseases; 87 are open to participants now.

This study's enrollment of 15 is below the median of 32 across 168 interventional studies indexed under Neuromuscular Diseases.

Browse Neuromuscular Diseases studies →

Lead sponsor

University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosis of NMD
  • Without respiratory exacerbation in the past 30 days
  • No prior knowledge of the AS or GPB techniques
  • Ability to understand instructions

Exclusion criteria

Exclusion Criteria:

  • Tracheostomized patients
  • Incomplete glottis closure
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Air Stacking

    Air Stacking was performed with the subject seated in his wheelchair using a manual resuscitation bag (LIFESAVER® model 5345, Hudson, Temecula, USA) connected to a corrugated tube with an internal diameter of 22 mm, a one-way valve and a pipette. The maximum capacity of the bag was 1600 mL. A chest physiotherapist insufflated the patient during the inspiratory phase, requesting that inspire as much air as possible

    Procedure: Air Stacking

  • Experimental
    Glossopharyngeal Breathing

    Glossopharyngeal Breathing was also performed with the subject seated in his wheelchair and performing successive maneuvers of "swallowing air" until the maximum volume achieve was maintained. Then, the patient was instructed to breathe through ventilometer to register the MIC. Three measurements for each of the techniques were performed, and the highest reading was recorded. A difference of \<10% between the measurements was used as the repeatability criterion

    Procedure: Glossopharyngeal Breathing

Interventions

  • ProcedureGlossopharyngeal Breathing

    Glossopharyngeal Breathing is a type of lung recruitment technique where the patients take a multiple inssuflations with their glossopharyngeal muscle.

  • ProcedureAir Stacking

    Air Stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a manual resuscitator.

06

What researchers measure

Primary outcomes

  1. Vital Capacity

    Vital Capacity is the volume of air expired after a maximal inspiration. The units are mililiters

    Time frame: 30 minutes

Secondary outcomes

  1. Peak Cough Flow

    The peak cough flow is the maximal flow generated after a cough. The units of measure are Liters per minute

    Time frame: 30 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02500030
Lead sponsor
University of Chile
Responsible party
Rodrigo Torres (Rodrigo Torres-Castro, University of Chile) — Principal investigator
First posted
Jul 16, 2015
Start date
Jun 2013
Primary completion
May 2014
Completion
Jun 2014
Last update
Jul 16, 2015

Study contacts

Homero Puppo, MSc
principal investigator · University of Chile

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion