The Effect of Pure Prone Positioning Therapy for the Patients With Mild to Moderate Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Efficacy of Pure Prone Positioning (PPP) treatment in improving apnea-hypopnea index (AHI) and nocturnal oxygen saturation was investigated in mild to moderate Obstructive Sleep Apnea.

Detailed Description
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Sleeping in prone position could be effective in the management of obstructive sleep apnea (OSA) by reducing the gravity effect on the upper airway and hence collapsibility. Pure prone positioning (PPP) consisted of a pillow mounted on a table designed to keep the subjects sleeping prone with the head extended in line with the body.

Official Title
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Efficacy Study of Pure Prone Positioning Therapy in Patients With Mild to Moderate Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Pure prone positioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were enrolled to the study among one hundred and eighty-four consecutive patients who were admitted to our sleep center with 6 beds in a tertiary care hospital, during 3 months period. Of these, 36 patients with mild to moderate OSA (AHI=5-30 events/h) were invited to participate in the study based on the selection criteria, and 29 patients with mild to moderate OSA on their baseline PSG, (17 males, 12 females) gave informed consent and participated in the study. Exclusion Criteria: Patients having BMI>35 and/or abdominal and/or trunkal obesity that may hinder prone sleeping , upper airway pathology (nasal polyp, nasal turbinate hypertrophy, chronic sinusitis, nasal septum deviation, upper airway infection, Mallampati score and tonsil size grade of IV), any other concomitant sleep disorder (narcolepsy, periodic leg movement syndrome, insomnia, sleep related hypoventilation-hypoxemia and central sleep apnea syndrome), psychiatric disorder such as panic disorder, heart failure and coronary artery disease were not included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pure Prone Positioning<br>Sleeping in prone position by pure prone positioning device, which consisted of a pillow mounted on a table designed to keep the subjects sleeping prone. | Device: Pure prone positioning<br>* Pure prone positioning device consisted of a pillow mounted on a table designed to keep the subjects sleeping prone.<br>* Other names: Positional treatment;|
| No Intervention: Baseline<br>No intervention for sleep position | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index (AHI) | Reduction in AHI during pure positioning night as compared to baseline night | ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night'' | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal oxygen saturation | Comparison of mean oxygen saturation, minimum oxygen saturation and proportion of time spent during sleep with oxygen saturation below 90% (as measures of nocturnal hypoxemia) in pure prone positioning night with that of the baseline night. | ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night'' | 
| Sleep efficiency | Improvement in sleep efficiency in prone positioning night as compared to baseline night. | ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night'' | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Prone positioning, Positional Treatment, Hypoxemia