- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01162317
AcuSleep in Mild Traumatic Brain Injury (TBI) (AcuTBI)
Novel Approaches to Sleep Difficulties: Application in Mild TBI
Objective: To evaluate real acupuncture, as compare to sham acupuncture, in improving persistent sleep difficulties in veterans with mild traumatic brain injury (mTBI) Design: Randomized, blinded, sham-controlled clinical trial Setting: Outpatient clinic at a major VA medical center in Southeast USA Participants: Sixty veterans aged 24-55 (mean 40) with history of mTBI at least 3-month and beyond, suffering from sleep difficulties refractory to regular care and sleep education, as indicated by a global Pittsburgh Sleep Quality Index (PSQI) score of 14.25 + 3.23 pre-intervention (baseline). They were randomized into 2 groups, real acupuncture versus sham acupuncture, and stratified by Post-traumatic stress disorder (PTSD) diagnosed by PTSD CheckList - Military Version (PCL-M).
Intervention: Real or sham acupuncture with both standardized and individualized acupoints selection. All subjects were informed that the treatments, if effective, may improve symptoms such as pain, anxiety or depression other than sleep; real acupuncture may not be effective in some individuals, and sham acupuncture may as well be effective by mind-body interactions.
Outcome Measures: Primary outcome measure was global PSQI score change after intervention as compared to baseline. Secondary outcome measure was wrist-actigraphy sleep latency, sleep efficiency, wake after sleep onset (WASO), and sleep duration. PTSD was analyzed as a co-variant.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Georgia
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Decatur, Georgia, États-Unis, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age: 18 to 55; and,
- Meeting the diagnosis criteria for mild traumatic brain injury as listed above at the time of injury; and,
- At or over 3 months post injury; and,
- With untreated sleep complaints (Pittsburgh Sleep Quality Index [PSQI] > 8, sleep difficulties at least 4x per week in the past month, average sleep duration of 6 hours or less); and,
- Has the capacity to give informed consent.
- Agree to attend 13 clinic visits
Exclusion Criteria:
- Same sleep complaints present prior to traumatic brain injury; or,
- Diagnosis of obstructive sleep apnea (OSA) by prior sleep study; or,
- With a non-daytime work-schedule; or,
- With prior acupuncture experience for the treatment of sleep difficulties or with acupuncture treatment within 3 months; or,
- History of bleeding diathesis or currently on anticoagulation with international normalized ratio (INR) over 2.5; or,
- Severe depression with Beck Depression Score of 29 and above; or,
- Moderate and severe alcohol users.
- Does not have a permanent address
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Arm 1: sham acupuncture
sham acupuncture
|
Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history.
A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment.
Acupoint selection will be based on a combination of standardization and individualization for best treatment effects.
At least 5 standardized body and auricular acupoints will be selected.
Standardized sterile, disposable acupuncture needles will be applied for 20 minutes.
Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration.
|
Expérimental: Arm 2: acupuncture
acupuncture
|
Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history.
A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment.
Acupoint selection will be based on a combination of standardization and individualization for best treatment effects.
At least 5 standardized body and auricular acupoints will be selected.
Standardized sterile, disposable acupuncture needles will be applied for 20 minutes.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
PSQI Change
Délai: Baseline and post-intervention
|
change of global PSQI score as compared to baseline The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The PSQI global score has a possible range of 0-21 points. Any score above 5 is considered insomnia. The higher the score the worse the condition. |
Baseline and post-intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency
Délai: pre-intervention, post-intervention (1wk of recording each)
|
Wrist actigraphy is a non-invasive method of continuously monitoring gross body activities when a watch-like actimetry sensor is worn at the non-dominant wrist.
An algorithm has been developed to assess sleep/wake behavior.
Specifically in this study, we used Respironics® actiwatches for data collection.
Subjects were asked to wear the actiwatches for a consecutive week at baseline and then at post-intervention, and the actiwatches were taken off only during showers.
Wrist actigraphy was examined in association with sleep diary the subjects were to keep for the weeks of monitoring.
Threshold-based method algorithm for data interpretation was provided by Respironics® Actiware Software.
Medium level threshold was set to detect Wake and Sleep; sleep interval detection algorithm was set for 3 minutes of immobile minutes for Sleep Onset and 5 minutes of immobile minutes for Sleep End.
Sleep efficiency is sleep duration divided by total bed time (both in minutes), times 100%.
|
pre-intervention, post-intervention (1wk of recording each)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wei Huang, MD PhD, Atlanta VA Medical and Rehab Center, Decatur, GA
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Troubles du sommeil et de l'éveil
- Blessures et Blessures
- Traumatisme crânio-cérébral
- Traumatisme, système nerveux
- Lésions cérébrales
- Troubles de l'initiation et du maintien du sommeil
- Lésions cérébrales, traumatiques
Autres numéros d'identification d'étude
- B6924-W
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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