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

This study has been completed.
Sponsor:
Information provided by:
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01368952
First received: June 6, 2011
Last updated: June 7, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Device: Pure prone positioning

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Study of Pure Prone Positioning Therapy in Patients With Mild to Moderate Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital:

Primary Outcome Measures:
  • Apnea-hypopnea index (AHI) [ Time Frame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night'' ] [ Designated as safety issue: No ]
    Reduction in AHI during pure positioning night as compared to baseline night


Secondary Outcome Measures:
  • Nocturnal oxygen saturation [ Time Frame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night'' ] [ Designated as safety issue: No ]
    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 [ Time Frame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night'' ] [ Designated as safety issue: No ]
    Improvement in sleep efficiency in prone positioning night as compared to baseline night.


Enrollment: 29
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: Pure prone positioning
Pure prone positioning device consisted of a pillow mounted on a table designed to keep the subjects sleeping prone.
Other Name: Positional treatment
No Intervention: Baseline
No intervention for sleep position

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01368952

Locations
Turkey
The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital
Izmir, Turkey, 35110
Sponsors and Collaborators
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Investigators
Principal Investigator: Arman Afrashi, MD The Department of Otolaryngology-Head and Neck Surgery, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
Study Director: Zeynep Z Ucar, MD The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
  More Information

Publications:
Responsible Party: Arman Afrashi, MD., Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01368952     History of Changes
Other Study ID Numbers: IGHCEAH-IRB-286, 286
Study First Received: June 6, 2011
Last Updated: June 7, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital:
Obstructive Sleep Apnea
Prone positioning
Positional Treatment
Hypoxemia

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014