NCT01368952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
Last Updated

June 8, 2011

Status Verified

May 1, 2011

Enrollment Period

2 months

First QC Date

June 6, 2011

Last Update Submit

June 7, 2011

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaProne positioningPositional TreatmentHypoxemia

Outcome Measures

Primary Outcomes (1)

  • 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''

Secondary Outcomes (2)

  • Nocturnal oxygen saturation

    ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''

  • Sleep efficiency

    ''Baseline PSG night'' and ''pure prone positioning night within two weeks of baseline PSG night''

Study Arms (2)

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.

Device: Pure prone positioning

Baseline

NO INTERVENTION

No intervention for sleep position

Interventions

Pure prone positioningDEVICE

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

Also known as: Positional treatment
Pure Prone Positioning

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Izmir, 35110, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 3363274BACKGROUND

  • 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.

    PMID: 8929648RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypoxia

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Zeynep Z Ucar, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 8, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 8, 2011

Record last verified: 2011-05

Locations

TU(1)