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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368952
• Other study ID #: IGHCEAH-IRB-286
• Secondary ID: 286
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: June 7, 2011
• Start date: March 2011
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Pure prone positioning
Pure prone positioning device consisted of a pillow mounted on a table designed to keep the subjects sleeping prone.

Locations

Country	Name	City	State
Turkey	The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

George CF, Millar TW, Kryger MH. Sleep apnea and body position during sleep. Sleep. 1988 Feb;11(1):90-9. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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''	No
Secondary	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''	No
Secondary	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''	No