Clinical trial NCT05346705: Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA
Official title: Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Muscle Disorder
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To observe the effect of newly-created individualized upper airway muscle functional training on the condition and intraday symptoms of OSA patients; to study the effect of this training method on the excitability of the genioglossus muscle cortex; to analyze the factors affecting the efficacy of upper airway training in the treatment of OSA and screening suitable population for upper airway training: Design: A randomized double-blind controlled trial. SAS 9.3 statistical software (SAS Institute, Cary, North Carolina, USA) was used to generate a random number table, and the selected patients were randomly divided into experimental group 1, experimental group 2, and control group according to the ratio of 1:1:1 with 100 cases each.

Unit: Shenyang, China Participants: Consecutive specific OSA patients, who are potential candidates for the treatment of upper airway training (n=300), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologists and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI\<40 kg/m2).

Interventions: The three groups of subjects completed 7-day functional training and control training of upper airway muscles in different modes, respectively completed polysomnography, neck circumference, Berlin questionnaire and Epworth sleepiness scale before and after training, The genioglossus myoelectric activity was measured after transcranial magnetic stimulation and the excitability of the genioglossus cortex motor center was used to determine the efficacy of different training. After regression analysis, the factors affecting the efficacy of upper airway muscle group training were analyzed to screen the OSA patient population suitable for upper airway muscle group training.


Eligibility criteria: Inclusion Criteria:

* Recent diagnosis of OSA (AHI\>15 events/h) announced by a sleep recording
* Mean oxygen saturation \>90%
* Must be able to complete the training

Exclusion Criteria:

* Inability to tolerate overnight polysomnography in sleep lab
* \>50% of observed sleep apneas being central
* Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome

Primary outcomes:
measure: Sleep Parameters Changes : Apnea Hypopnea Index (AHI)
timeFrame: Baseline and 1 Week
measure: Sleep Parameters Changes : Oxygen desaturation index (ODI)
timeFrame: Baseline and 1 Week
measure: Sleep Parameters Changes : Snoring index
timeFrame: Baseline and 1 Week
Secondary outcomes:
measure: Upper Airway Muscle Strength (genioglossus)
timeFrame: Baseline and 1 Week
measure: Upper Airway Muscle Strength (Soft palate muscles)
timeFrame: Baseline and 1 Week
measure: Quality of Life (as measured by Berlin Questionnaire)
timeFrame: Baseline and 1 Week
measure: Cortical motor center excitability of upper airway muscle
timeFrame: Baseline and 1 Week
measure: Daytime sleepiness (as measured by Epworth Sleepiness Scale)
timeFrame: Baseline and 1 Week
Other outcomes:
Locations:
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
Study officials:
References: