Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Apnoea-hypopnoea index (AHI) |
Change in apnea (airflow reduction greater than or equal to 90%) and hypopnea (airflow reduction greater than or equal to 30%) episodes per hour of sleep measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Oxygen desaturation index (ODI) |
Change in the number of oxygen desaturations greater than or equal to 4%/h measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Oxygen saturation (SaO2) mean |
Change in the average of oxygen saturation measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Oxygen saturation (SaO2) nadir |
Minimum oxygen saturation measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Sleep efficiency |
Change in the total sleep time/total time in bed measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Light sleep (N1 and N2 stages) |
Change in the percentage of light sleep (N1 and N2 stages) measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Deep sleep (N3 stage) |
Change in the percentage of deep sleep (N3 stage) measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Rapid eye movement (REM) sleep |
Change in the percentage of REM sleep measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Excessive daytime sleepiness (EDS) |
Change in the difficulty in maintaining a desired level of wakefulness, measured by the Epworth sleepiness scale (ESS) from baseline to post-intervention. ESS is a 4-point scale (0 = no chance of dozing, 1 = slight chance of dozing, 2 = moderate chance of dozing, 3 = high chance of dozing) that measures the usual chances of dozing off or falling asleep while engaged in eight different activities. An ESS total score from 0 to 9 is considered to be normal while an ESS total score > 9 indicates high daytime sleepiness. |
Post-intervention (2 months) |
|
| Secondary |
Sleep Quality |
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention. This scale includes a total of 19 self-rated items combined to form seven component scores i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction), each of which has a range of 0-3 points. The sum of these seven PSQI component scores is considered to obtain a global PSQI score (ranging from 0-21), with higher scores indicating poorer sleep quality. |
Post-intervention (2 months) |
|
| Secondary |
Wake After Sleep Onset (WASO) |
Change in Wake After Sleep Onset (WASO; minutes) measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Fat mass (kg) |
Change in fat mass (kg) measured by a whole-body densitometry using dual-energy X-ray absorptiometry (DEXA), from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Visceral adipose tisue (g) |
Change in visceral adipose tisue (g) measured by a whole-body densitometry using dual-energy X-ray absorptiometry (DEXA), from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Body weight (kg) |
Change in body weight (kg) measured by a scale from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Neck circumference (cm) |
Change in neck circumference (cm) measured by a tape measure from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Chest circumference (cm) |
Change in chest circumference (cm) measured by a tape measure from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Waist circumference (cm) |
Change in waist circumference (cm) measured by a tape measure from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Mean blood pressure (mm HG) |
Change in mean blood pressure (mm HG) measured by a blood pressure cuff from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Plasma glucose (mg/dL) |
Change in plasma glucose (mg/dL) measured by a blood test from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Change in total cholesterol (mg/dL) from baseline to post-intervention |
Change in total cholesterol (mg/dL) measured by a blood test from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
| Secondary |
Change in total triglycerides (mg/dL) from baseline to post-intervention |
Change in total triglycerides (mg/dL) measured by a blood test from baseline (week 0) to post-intervention (2 months) |
Post-intervention (2 months) |
|
