Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome. (NOCTURNE)

Centre Hospitalier Régional d'Orléans

Status: Enrolling

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Other: Inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT06117579

CHRO-2023-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Inspiratory muscle training group

Experimental group

Description:

Step 1: During the consultation to diagnose obstructive sleep disorder with the pulmonologist (following polysomnography) to set up continuous positive airway pressure (CPAP): * Introduction of CPAP * Epworth Sleepiness Scale (ESS) * Maximum Inspiratory Pressure (MIP) measurement * Explanation of exercise program and use of POWERBreathe Step 2: 6-week telephone follow-up with measurement of Epworth Sleepiness Scale (ESS) Step 3: Follow-up visit at 12 weeks after introduction of CPAP: * Review of CPAP implementation * Epworth Sleepiness Scale (ESS) * MIP measurement

Treatment:

Other: Inspiratory muscle training

Control group

No Intervention group

Description:

Step 1: During the consultation to diagnose obstructive sleep disorder with the pulmonologist (following polysomnography) to set up continuous positive airway pressure (CPAP): * Introduction of CPAP * Epworth Sleepiness Scale (ESS) * Maximum Inspiratory Pressure (MIP) measurement Step 2: 6-week telephone follow-up with measurement of Epworth Sleepiness Scale (ESS) Step 3: Follow-up visit at 12 weeks after introduction of CPAP: * Review of CPAP implementation * Epworth Sleepiness Scale (ESS) * MIP measurement