Wake Training + TMR for Sleep Apnea

Overseen By Ken A Paller, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Other sleep disorders, Neurological, Cardiometabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining breathing exercises while awake with specific brain activation during sleep (known as Wake Training + TMR) can improve breathing during sleep and enhance mental sharpness when awake. It targets individuals with obstructive sleep apnea who have not yet begun treatment. Participants will practice breathing exercises at home for a week and then have their sleep monitored for one night in a lab. Ideal candidates are those who suspect they have sleep apnea and have not received treatment. This trial may suit individuals whose sleep apnea symptoms disrupt daily life. As an unphased study, it offers a unique opportunity to contribute to innovative research that could enhance treatment options for sleep apnea.

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 prior data suggests that this method is safe for sleep apnea patients?

Research has shown that breathing exercises can help individuals with obstructive sleep apnea (OSA). One study found that these exercises improved the Apnea-Hypopnea Index (AHI), which measures breathing issues during sleep, suggesting that breathing exercises are generally safe and beneficial.

Targeted Memory Reactivation (TMR) has been used in other areas, such as enhancing memory during sleep. For instance, TMR has been safely applied in memory-related therapies.

Although specific safety data for the new combination treatment (wake training plus TMR) is not yet available, both techniques have been safely used in other studies. This suggests that the treatment could be well-tolerated. However, as the study is still in progress, concrete safety data for this combination is not yet available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Wake Training + TMR (Targeted Memory Reactivation) for sleep apnea because it offers a novel approach compared to traditional treatments like CPAP machines or oral appliances. Unlike these standard options that physically manage airflow or reposition the jaw, Wake Training + TMR focuses on retraining the brain's responses during sleep. This method aims to enhance the natural sleep architecture and improve breathing patterns without the need for external devices, potentially leading to a more comfortable and sustainable solution for sleep apnea sufferers.

What evidence suggests that this wake training + TMR is effective for sleep apnea?

Research has shown that targeted memory reactivation (TMR) during sleep can boost learning and memory. In studies, participants who experienced TMR performed better on tasks involving new skill acquisition. This suggests that TMR strengthens memories and might enhance cognitive abilities. Similarly, practicing breathing exercises while awake is believed to improve breathing patterns, potentially reducing sleep apnea symptoms. Although direct evidence for using both methods together for sleep apnea is limited, the underlying concepts suggest they might aid learning and breathing during sleep. In this trial, all participants will receive the combined Wake Training and TMR intervention to explore its potential benefits for sleep apnea. ^{6 7 8 9 10}

Who Is on the Research Team?

Ken A Paller, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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

No report of any other sleep disorder besides OSA

I might have sleep apnea, diagnosed by a doctor or based on my symptoms.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: All participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12426868/

Enhancing Motor Learning in People With Stroke Via ... ... TMR and NoTMR groups. The main results indicate that participants who received TMR during sleep demonstrated greater reductions in both absolute error and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1053811921008466

Long term effects of cueing procedural memory reactivation ... A single night of TMR benefits procedural memories up to 10 days later. Spindle density and SO-spindle coupling strength increase immediately upon cue onset.

3. biorxiv.org biorxiv.org/content/10.1101/2024.09.25.615100v1.full-text

Interpreting Sleep Activity Through Neural Contrastive ... This dataset includes about 1,000 hours of sleep and 400 hours of awake task data, providing numerous instances of the same memories being ...

4. nature.com nature.com/articles/s41539-024-00276-0

Targeted memory reactivation with sleep disruption does ... On the basis of those results, we designed a study using TMR-SD to intentionally cause arousals, and we observed selective memory weakening.

5. researchgate.net researchgate.net/publication/317849932_Targeted_Memory_Reactivation_During_Sleep_But_Not_Wake_Enhances_Sensorimotor_Skill_Performance_A_Pilot_Study

Targeted Memory Reactivation During Sleep, But Not Wake ... The main results indicate that participants who received TMR during sleep demonstrated greater reductions in both absolute error and variable error compared ...

6. withpower.com withpower.com/clinical-trials/for-osa

Top Osa Clinical Trials | Power This study will examine whether a combination of breathing training during wake and targeted reactivation of the training during sleep can induce breathing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4865554/

Overnight Motor Skill Learning Outcomes in Obstructive ... In summary, the current study is consistent with previous investigations, showing that patients with OSA display deficient overnight motor skill learning.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.14290

Oral Sessions - 2024 - Journal of Sleep Research Results: Initial OSA diagnosis confirmed by polysomnography (PSG) revealed an average AHI of 28.79 ± 14.40 /h and a baseline REMOV of 24.17 ± ...

9. researchgate.net researchgate.net/publication/356691422_Effects_of_respiratory_training_on_obstructive_sleep_apnea_systematic_review_and_meta-analysis

Effects of respiratory training on obstructive sleep apnea Results of this meta-analysis suggests that breathing exercises lead to a measurable improvement in AHI for patients with mild to moderate OSA.

10. cell.com cell.com/current-biology/pdfExtended/S0960-9822(22)01477-4

Enhancing imagery rehearsal therapy for nightmares with ... We here used targeted memory reactivation (TMR) during REM sleep to strengthen IRT-related memories and accelerate remis- sion of ND. Thirty-six ...