Sleep Disordered Breathing and Chronic Pain
BiPAP Adaptive Servo-Ventilation (AutoSV) Therapy in Patients With Chronic Pain and Sleep Disordered Breathing (SDB)
調査の概要
状態
条件
詳細な説明
Purpose: Opioid treatment of non-malignant chronic pain can result in hypoxemia, hypercarbia, and central sleep apnea. The aim of this study was to determine the initial efficacy of auto servo-ventilation (ASV) and after 3 months of home use.
Methods: This prospective multicenter interventional study recruited chronic pain patients prescribed ≥100 morphine equivalents for at least 4 months.
Participants: Following full-night polysomnography (PSG) to confirm the presence of sleep-disordered breathing, patients were randomized to three additional full-night-attended PSGs with continuous positive airway pressure (CPAP), ASV, and servo-ventilation with an initial mandatory pressure support of 6 cm water (H2O) ASV manual Minimum Pressure Support (PSmin). Following the PSGs, patients were sent home with EncoreAnywhere and ASV with or without mandatory pressure support.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35213
- Sleep D/O Center of Alabama
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Arkansas
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Little Rock、Arkansas、アメリカ、72211
- Arkansas Center for Sleep Medicine
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Georgia
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Atlanta、Georgia、アメリカ、30342
- NeuroTrials Research Inc.
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Missouri
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St. Louis、Missouri、アメリカ、63143
- Clayton Sleep Institute
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Males and females, ages 21-70.
- Able to provide written informed consent.
- Diagnosis of chronic non-malignant pain (pain present for ≥ 6 months).
- Stable regimen of opioids (oral, transdermal, and/or intravenous) for chronic pain for at least 4 weeks prior to study participation with a prescribed opioid dose equal to at least 100 milliequivalents of morphine per 24 hours (Appendix 1).
- Agreement to undergo an in-lab Diagnostic polysomnography (PSG) demonstrating an Apnea-Hypopnea Index (AHI) of at least 20 and Central Apnea Index (CAI) ≥ 10 events per hour of sleep OR at least 25% of Total Sleep Time (TST) below 90% Oxygen Saturation (SAO2) saturation and AHI ≥ 10
- Agreement to undergo 3 full-night, in-lab PSG's on positive airway pressure therapy.
- Agreement to undergo breathalyzer testing prior to each PSG visit
- Ability to provide reliable documentation of opioid medications (ex. Pharmacy records) as treatment for chronic pain for the previous 30 days.
- Willingness to undergo urine drug screening.
Exclusion Criteria:
- Participation in other interventional, sleep or pharmaceutical related research studies within 30 days prior to giving consent.
- Workers with variable shift schedules.
- Previous treatment with positive airway pressure therapy within 90 days of providing consent.
- Participants with any conditions in which positive airway pressure is medically contraindicated (e.g. recent pneumothorax, systolic BP < 80 mmHg).
- BMI > 40
- Unwilling to wear PAP.
- Any surgery involving the upper airway, eye, nose, sinuses or middle ear within the last 90 days.
- Major or poorly managed medical or psychiatric condition that would interfere with the demands of the study, to the use of positive airway pressure, or the ability to complete the study.
- Previous diagnosis of severe chronic obstructive pulmonary disease (COPD) with an forced expiratory volume at one second (FEV1) < 1 liter or less than 50% predicted
- Presence of elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 50mmHg) due to intrinsic lung disease, neuromuscular or musculoskeletal disorders.
- Participants currently prescribed 24 hour oxygen therapy (nocturnal O2 therapy for obstructive sleep apnea (OSA) treatment is allowed)
- Females who are pregnant or, if of child bearing potential, not currently using medically reliable birth control methods.
- Participants prescribed opioids for reasons other than the management of chronic, non-malignant pain.
- Failure of two consecutive breathalyzer tests from study PSG nights
- Periodic Limb Movements (PLM's) with arousals > 15
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:servo ventilation auto mode
Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
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Expiratory pressure automatically adjusted to stabilize the upper airway.
Inspiratory pressure automatically adjusted to deliver consistent peak flow.
continuous positive airway pressure
他の名前:
servo ventilation titrated in manual mode
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アクティブコンパレータ:Continuous positive airway pressure
Airway pressure delivered at a constant pressure level.
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continuous positive airway pressure
他の名前:
servo ventilation titrated in manual mode
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アクティブコンパレータ:servo ventilation manual
Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
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servo ventilation titrated in manual mode
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of Sleep Related Events Per Hour
時間枠:four full night Polysomnography (PSG's)
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The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.
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four full night Polysomnography (PSG's)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percent Oxygen Saturation
時間枠:four full night Polysomnography (PSG's)
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Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.
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four full night Polysomnography (PSG's)
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Number of Arterial Oxygen Saturation Per Hour
時間枠:four full night Polysomnography (PSG's)
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Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.
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four full night Polysomnography (PSG's)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Mark Muehlbach, PhD、Clayton Sleep Institute
- 主任研究者:Paul Wylie, MD、Arkansas Center of Sleep Medicine
- 主任研究者:Vernon Pegram, PhD、Sleep D/O Center of Alabama
- 主任研究者:Russell Rosenberg, MD、NeuroTrials Research, Inc.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
睡眠時無呼吸症候群の臨床試験
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University Hospital, Bonnわからない合併症 | 睡眠時無呼吸 (Apnea Hypopnea Index > 5/h として定義) | 頭蓋内動脈瘤のサイズ | 血圧の薬 | 合併症(くも膜下出血)ドイツ
servo ventilation autoの臨床試験
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University Hospital Inselspital, BerneSwiss National Science Foundation; TROPOS Stiftung für Humane Verhaltensforschung積極的、募集していない
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Fisher and Paykel HealthcareHelios Klinik Ambrock完了
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Centre d'Investigation Clinique et Technologique...Adep Assistance完了
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Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)募集