50 Participants Needed

Wake Training + TMR for Sleep Apnea

KA
Overseen ByKen A Paller, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Wake training + TMR for sleep apnea?

Inspiratory muscle training (IMT), a component of the treatment, has been shown to improve inspiratory muscle strength, sleep quality, and reduce daytime sleepiness in people with obstructive sleep apnea (OSA). Additionally, orofacial myofunctional reeducation (OMR), another similar therapy, has been effective in reducing the severity of OSA and improving sleep quality.12345

Is Wake Training + TMR for Sleep Apnea safe for humans?

Daytime neuromuscular electrical training (NMES) of tongue muscles, which is similar to Wake Training + TMR, was found to be safe in a study with no serious side effects reported. It was well tolerated by participants, with only minimal temporary side effects.46789

How is the Wake Training + TMR treatment for sleep apnea different from other treatments?

Wake Training + TMR is unique because it combines wake training, which may involve exercises to improve muscle function, with targeted memory reactivation (TMR) during sleep. This approach is different from traditional treatments like CPAP (continuous positive airway pressure) machines, as it focuses on training and potentially enhancing the body's natural ability to maintain open airways during sleep.29101112

What is the purpose of this trial?

This study will examine whether a combination of breathing training during wake and targeted reactivation of the training during sleep can induce breathing changes during sleep and subsequent cognitive benefits during wake.Participants with obstructive sleep apnea (who have not yet been treated for sleep apnea) will be recruited. Participants will engage in breath training for one week in their own homes and to record their sleep at home using commercially available mobile devices and subsequently have their sleep monitored for one night of polysomnography recordings plus targeted reactivation in a laboratory setting.

Research Team

KA

Ken A Paller, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for individuals with untreated obstructive sleep apnea. Participants will practice breath training at home for a week and have their sleep recorded using mobile devices, followed by one night of detailed sleep study in a lab.

Inclusion Criteria

BMI ≤ 40
I might have sleep apnea, diagnosed by a doctor or based on my symptoms.
No report of any other sleep disorder besides OSA
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Breath Training

Participants engage in breath training for one week in their own homes and record their sleep using mobile devices

1 week

Polysomnography and Targeted Reactivation

Participants have their sleep monitored for one night of polysomnography recordings plus targeted reactivation in a laboratory setting

1 night

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Wake training + TMR
Trial Overview The study tests if wake breathing training combined with targeted memory reactivation during sleep can improve breathing patterns during rest and cognitive function while awake in those with obstructive sleep apnea.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention

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Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Findings from Research

Inspiratory muscle training (IMT) over 12 weeks significantly improved sleep quality in patients with obstructive sleep apnea (OSA), as measured by the Pittsburgh Sleep Quality Index, compared to a placebo group.
However, IMT did not lead to significant improvements in lung function, respiratory muscle strength, or exercise capacity, indicating that while it may enhance sleep quality, it does not affect overall physical performance in OSA patients.
Effectiveness of inspiratory muscle training on sleep and functional capacity to exercise in obstructive sleep apnea: a randomized controlled trial.Souza, AKF., Dornelas de Andrade, A., de Medeiros, AIC., et al.[2019]
Orofacial myofunctional reeducation (OMR) significantly reduces the Apnea-Hypopnea Index (AHI) in both children (up to 90.6%) and adults (up to 92.06%), indicating its effectiveness in treating obstructive sleep apnea syndrome (OSA).
Passive OMR, particularly with the use of a custom orthosis, enhances treatment adherence and improves outcomes such as snoring intensity and upper airway function, making it a valuable option in the management of OSA.
[The contribution of orofacial myofunctional reeducation to the treatment of obstructive sleep apnoea syndrome (OSA): a systematic review of the literature].Amat, P., Tran Lu Y, É.[2021]

References

Inspiratory Muscle Training for Obstructive Sleep Apnea: Protocol Development and Feasibility of Home Practice by Sedentary Adults. [2022]
Effectiveness of inspiratory muscle training on sleep and functional capacity to exercise in obstructive sleep apnea: a randomized controlled trial. [2019]
Effects of inspiratory muscle training in patients with obstructive sleep apnoea syndrome: a systematic review and meta-analysis. [2022]
Effectiveness of respiratory muscle training for patients with obstructive sleep apnea: A protocol of systematic review and meta-analysis. [2023]
[The contribution of orofacial myofunctional reeducation to the treatment of obstructive sleep apnoea syndrome (OSA): a systematic review of the literature]. [2021]
Evaluation of a Trial Period With a Sleep Position Trainer in Patients With Positional Sleep Apnea. [2019]
Can respiratory muscle training therapy effectively manage obstructive sleep apnea syndrome after stroke?: A protocol of systematic review and meta-analysis. [2022]
Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring in Individuals with Primary Snoring and Mild Obstructive Sleep Apnea. [2021]
New-generation positional therapy in patients with positional central sleep apnea. [2020]
Effects of respiratory muscle training (RMT) in patients with mild to moderate obstructive sleep apnea (OSA). [2019]
Lip muscle training improves obstructive sleep apnea and objective sleep: a case report. [2020]
The effects of threshold inspiratory muscle training in patients with obstructive sleep apnea: a randomized experimental study. [2021]
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