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Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

Study acronym: NOCTURNE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Dec 1, 2025 to Oct 25, 2026
    • Study completion date: Jan 1, 2026 to Jan 25, 2027
    v9
  2. Minor Publications: 3 to 6
    • Study description shortened, about 5 words
    v8
  3. Minor Study description expanded, about 272 wordsv7
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2024 to Jun 26, 2024
    • Site details revised
    v6
  5. Minor Start date: May 2024 to Jun 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Jan 29, 2024 to May 2024v4
  2. Notable Start date: Dec 1, 2023 to Jan 29, 2024v3
  3. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06117579
Lead Sponsor Centre Hospitalier Régional d'Orléans
Conditions
(from sponsor)
Obstructive Sleep Apnea of Adult
Related terms Sleep Apnea, Obstructive
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov