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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Pure prone positioning

• Registration Number: NCT01368952
• Lead Sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-07
• Last Update Submitted: 2011-06-07
• Study First Posted: 2011-06-08
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pure Prone Positioning	Pure prone positioning	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.

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index (AHI)	''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''	Reduction in AHI during pure positioning night as compared to baseline night

Secondary Outcome Measures

Name	Time	Method
Nocturnal oxygen saturation	''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''	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.
Sleep efficiency	''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''	Improvement in sleep efficiency in prone positioning night as compared to baseline night.

Trial Locations

Locations (1)

The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital; 🇹🇷 Izmir, Turkey