Muscle Disorder, Obstructive Sleep Apnea
Conditions
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.
Interventions
BEHAVIORALNew individualized upper airway muscle functional training
The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.
Sponsors
First Hospital of China Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Parameters Changes : Apnea Hypopnea Index (AHI) | Baseline and 1 Week | Overnight polysomnography with Alice5 (Philips); AHI measured according to American Association of Sleep Medicine (AASM) criteria |
| Sleep Parameters Changes : Oxygen desaturation index (ODI) | Baseline and 1 Week | Overnight polysomnography with Alice5 (Philips); ODI measured according to American Association of Sleep Medicine (AASM) criteria |
| Sleep Parameters Changes : Snoring index | Baseline and 1 Week | Overnight polysomnography with Alice5 (Philips); Snoring index measured according to American Association of Sleep Medicine (AASM) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cortical motor center excitability of upper airway muscle | Baseline and 1 Week | Measured byTranscranial Magnetic Stimulation Machine (Nihon Nkohdencorp) : amplitude (mV) |
| Upper Airway Muscle Strength (genioglossus) | Baseline and 1 Week | Measurement of Genioglossus Strength Using the New Individualized Upper Airway Muscle Training Machine: Measuring Tongue Extension Strength (N) |
| Daytime sleepiness (as measured by Epworth Sleepiness Scale) | Baseline and 1 Week | Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness). |
| Upper Airway Muscle Strength (Soft palate muscles) | Baseline and 1 Week | Measuring Soft Palate Muscle Strength Using the New Personalized Upper Airway Muscle Training Machine: Measuring Soft Palate Muscle Resistant Pressure (kPa) |
| Quality of Life (as measured by Berlin Questionnaire) | Baseline and 1 Week | The Berlin scale was used to assess the degree of risk of obstructive sleep apnea-hypopnea syndrome. The questionnaire consisted of 10 questions divided into 3 categories: snoring and apnea (5 questions); excessive daytime sleepiness or fatigue (3 questions); BMI\>30 and history of hypertension. 2 or more positive results indicate a high risk of obstructive sleep apnea-hypopnea syndrome, which should be checked by the subjects, and then scored by the medical staff. |
Countries
China
Contacts
Primary ContactWenyang Li, PhD
Outcome results
None listed