Clinical trial NCT01368952: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Prone positioning
Positional Treatment
Hypoxemia
Lead sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
Secondary outcomes:
measure: Nocturnal oxygen saturation
timeFrame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
measure: Sleep efficiency
timeFrame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital
Study officials:
affiliation: The Department of Otolaryngology-Head and Neck Surgery, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
name: Arman Afrashi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
name: Zeynep Z Ucar, MD
role: STUDY_DIRECTOR
References:
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.
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.