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Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

Effect of Inspiratory Muscle Training on Daytime Sleepiness in Obstructive Sleep Apnea Syndrome : Prospective Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06117579
Acronym
NOCTURNE
Enrollment
58
Registered
2023-11-07
Start date
2024-06-26
Completion date
2027-01-25
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Obstructive Sleep Apnea, Inspiratory muscle training

Brief summary

Sleep apnea-hypopnea syndrome is a sleep-related respiratory disorder characterized by partial or total interruptions in breathing during sleep. The majority of syndromes involve an obstructive mechanism (OSA), caused by a reduction in the caliber of the upper airway (UA), most often associated with hypotonia of the surrounding muscles, preventing air from entering the UA during inspiration. The clinical consequences of this syndrome are excessive fatigue and daytime sleepiness, which have a negative impact on the quality of life of patients. Despite the positive results on apnea-hypopnea index and daytime sleepiness of continuous positive airway pressure (today's reference treatment), its 3-year compliance rate (i.e 59.9% according to a study by Abdelghani et al points to the need to develop other associated therapies. Several studies have demonstrated the efficacy of physiotherapy, such as physical activity and oro-pharyngeal muscle strengthening, notably on the apnea-hypopnea index and daytime sleepiness measured by the Epworth scale. Few studies have investigated the effect of inspiratory muscle training (IMT), even though the use of the inspiratory musculature (i.e. the diaphragm) is a means of supplementing the peri-pharyngeal muscles, as it helps to maintain the permeability of the upper airways. Inspiratory muscle training (IMT) could therefore be considered as part of the physiotherapeutic management of the OSA. The heterogeneity of current results concerning IMT in OSA , but above all the lack of evidence that it is dangerous, means that new clinical studies could be carried out in an attempt to demonstrate its efficacy. Our research hypothesis is therefore as follows: Implementing an inspiratory muscle strengthening protocol in patients suffering from OSA can reduce daytime sleepiness.

Detailed description

Sleep apnea-hypopnea syndrome is a sleep-related respiratory disorder characterized by partial or total interruptions in breathing during sleep. The majority of syndromes involve an obstructive mechanism (OSA), caused by a reduction in the caliber of the upper airway (UA), most often associated with hypotonia of the surrounding muscles, preventing air from entering the UA during inspiration. The clinical consequences of this syndrome are excessive fatigue and daytime sleepiness, which have a negative impact on the quality of life of patients. Despite the positive results on apnea-hypopnea index and daytime sleepiness of continuous positive airway pressure (today's reference treatment), its 3-year compliance rate (i.e 59.9% according to a study by Abdelghani et al points to the need to develop other associated therapies. Several studies have demonstrated the efficacy of physiotherapy, such as physical activity and oro-pharyngeal muscle strengthening, notably on the apnea-hypopnea index and daytime sleepiness measured by the Epworth scale. Few studies have investigated the effect of inspiratory muscle training (IMT), even though the use of the inspiratory musculature (i.e. the diaphragm) is a means of supplementing the peri-pharyngeal muscles, as it helps to maintain the permeability of the upper airways. Inspiratory muscle training (IMT) could therefore be considered as part of the physiotherapeutic management of the OSA. The heterogeneity of current results concerning IMT in OSA , but above all the lack of evidence that it is dangerous, means that new clinical studies could be carried out in an attempt to demonstrate its efficacy. Our research hypothesis is therefore as follows: Implementing an inspiratory muscle strengthening protocol in patients suffering from OSA can reduce daytime sleepiness.

Interventions

OTHERInspiratory muscle training

Description of a typical session: Session duration: between 12 and 20 minutes 3 cycles of 30 repetitions with 1 minute of break between each cycle. The patient should inhale as hard as possible against an inspiratory resistance generated by a valve device.

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients over 18 years of age with * OSA with an Apnea Hypopnea Index ≥ 5 requiring CPAP

Exclusion criteria

* Sleep apnea of neurological or mixed origin, * Contraindication to or refusal of CPAP, * Cognitive disorders, * protected persons (under guardianship or curatorship), * persons under court protection, * persons not affiliated to a social security scheme * pregnant or breast-feeding women.

Design outcomes

Primary

MeasureTime frameDescription
Change in Daytime sleepiness12 weeksChange in daytime sleepiness measured by the Epworth Sleepiness Scale following the introduction of IMT combined with CPAP Epworth Sleepiness Scale ranged from 0 (it is unlikely that you are abnormally sleepy) to 24 (you are excessively sleepy and should consider seeking medical attention).

Countries

France

Contacts

Primary ContactAurelie DESPUJOLS, Msc
aurelie.despujols@chu-orleans.fr+332 38 74 40 71

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026