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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pure prone positioning
Sponsored by
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Prone positioning, Positional Treatment, Hypoxemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pure Prone Positioning

Baseline

Arm Description

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.

No intervention for sleep position

Outcomes

Primary Outcome Measures

Apnea-hypopnea index (AHI)
Reduction in AHI during pure positioning night as compared to baseline night

Secondary Outcome Measures

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.
Sleep efficiency
Improvement in sleep efficiency in prone positioning night as compared to baseline night.

Full Information

First Posted
June 6, 2011
Last Updated
June 7, 2011
Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01368952
Brief Title
The Effect of Pure Prone Positioning Therapy for the Patients With Mild to Moderate Obstructive Sleep Apnea
Official Title
Efficacy Study of Pure Prone Positioning Therapy in Patients With Mild to Moderate Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, Prone positioning, Positional Treatment, Hypoxemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pure Prone Positioning
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Baseline
Arm Type
No Intervention
Arm Description
No intervention for sleep position
Intervention Type
Device
Intervention Name(s)
Pure prone positioning
Other Intervention Name(s)
Positional treatment
Intervention Description
Pure prone positioning device consisted of a pillow mounted on a table designed to keep the subjects sleeping prone.
Primary Outcome Measure Information:
Title
Apnea-hypopnea index (AHI)
Description
Reduction in AHI during pure positioning night as compared to baseline night
Time Frame
''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
Secondary Outcome Measure Information:
Title
Nocturnal oxygen saturation
Description
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.
Time Frame
''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
Title
Sleep efficiency
Description
Improvement in sleep efficiency in prone positioning night as compared to baseline night.
Time Frame
''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arman Afrashi, MD
Organizational Affiliation
The Department of Otolaryngology-Head and Neck Surgery, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeynep Z Ucar, MD
Organizational Affiliation
The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
Official's Role
Study Director
Facility Information:
Facility Name
The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital
City
Izmir
ZIP/Postal Code
35110
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
3363274
Citation
George CF, Millar TW, Kryger MH. Sleep apnea and body position during sleep. Sleep. 1988 Feb;11(1):90-9. doi: 10.1093/sleep/11.1.90.
Results Reference
background
PubMed Identifier
8929648
Citation
Matsuzawa Y, Hayashi S, Yamaguchi S, Yoshikawa S, Okada K, Fujimoto K, Sekiguchi M. Effect of prone position on apnea severity in obstructive sleep apnea. Intern Med. 1995 Dec;34(12):1190-3. doi: 10.2169/internalmedicine.34.1190.
Results Reference
result

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

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