Obstructive Sleep ApneaNCT01368952
The Effect of Pure Prone Positioning Therapy for the Patients With Mild to Moderate Obstructive Sleep Apnea
A study testing Pure prone positioning in people with Obstructive Sleep Apnea, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Pure prone positioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2011to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital
Izmir, 35110
About this study
Official title: Efficacy Study of Pure Prone Positioning Therapy in Patients With Mild to Moderate Obstructive Sleep Apnea
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Pure prone positioning
- Keywords
- Obstructive Sleep Apnea, Prone positioning, Positional Treatment, Hypoxemia
- Medical subject headings
- Sleep Apnea, Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure prone positioningDevice
Also called Positional treatment
Pure prone positioning device consisted of a pillow mounted on a table designed to keep the subjects sleeping prone.
| Study group | Role | What they receive |
|---|---|---|
| Pure Prone Positioning | Active comparator | 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. Receives: Device: Pure prone positioning |
| Baseline | No intervention | No intervention for sleep position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI)
Reduction in AHI during pure positioning night as compared to baseline night
Measured: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
Secondary outcomes (2)
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.
Measured: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
Sleep efficiency
Improvement in sleep efficiency in prone positioning night as compared to baseline night.
Measured: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Arman Afrashi, MD, Principal investigator, The Department of Otolaryngology-Head and Neck Surgery, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, TurkeyZeynep Z Ucar, MD, Study director, The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368952
- Sponsor's protocol ID
- IGHCEAH-IRB-286
- Other IDs
- 286
- Status last verified
- May 2011
- First submitted
- 6 Jun 2011
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3363274Matsuzawa 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.
PubMed 8929648
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Pure Prone Positioning Therapy in Patients With Mild to Moderate Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01368952
- Acronym / sponsor ID
- IGHCEAH-IRB-286
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Prone positioning, Positional Treatment, Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pure Prone Positioning | Active comparator | Device: Pure prone positioningSleeping in prone position by pure prone positioning device, which consisted of a pillow mounted on a table designed to keep the subjects sleeping prone. |
| Baseline | No intervention | –No intervention for sleep position |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure prone positioningAlso: Positional treatmentPure prone positioning device consisted of a pillow mounted on a table designed to keep the subjects sleeping prone. | Device | Pure Prone Positioning |
Primary outcome
Apnea-hypopnea index (AHI)
Time frame: ''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
2 secondary outcomes
Nocturnal oxygen saturation
Time frame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
Sleep efficiency
Time frame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Background: PubMed 3363274George 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 publication: PubMed 8929648Matsuzawa 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.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arman Afrashi, MD principal investigator
The Department of Otolaryngology-Head and Neck Surgery, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
Zeynep Z Ucar, MD study director
The Department of Sleep Disorders, Izmir Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Izmir, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pure prone positioning in people with Obstructive Sleep Apnea, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (AHI) (time frame: ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01368952, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.