American Heart Association- Stroke/Hypoxia Study
Cuvinte cheie
Abstract
Descriere
Stroke is the second leading cause of death and a leading cause of long-term disability worldwide. Despite the spontaneous recovery that occurs following a hemispheric stroke, more than half of stroke patients show substantial residual impairments, imposing a significant human and economic burden. This burden is likely to increase in coming decades, due to a rapidly aging population, and the associated progression of cardiovascular risk factors. Accordingly, new interventions to alleviate impairment in stroke survivors are urgently needed. The development and testing of one such novel intervention, termed Acute Intermittent Hypoxia (AIH), is the primary focus of this AHA Innovative Project Award.
The aim is to answer questions related to safety and preliminary efficacy of AIH in stroke survivors. First, the Investigators will establish whether brief reductions in inhaled oxygen concentration can be safely tolerated in stroke survivors. A clinician will closely monitor subjects for any adverse events.
The second aim is to establish the effects of AIH on elbow flexion/extension strength, and on hand grip and pinch strength. Subjects will be monitored closely for any adverse events during these experiments. Data will be analyzed to determine if there is an improvement in key outcomes at any dose level.
Datele
| Ultima verificare: | 02/29/2020 |
| Primul depus: | 06/18/2019 |
| Inscriere estimată trimisă: | 07/11/2019 |
| Prima postare: | 07/14/2019 |
| Ultima actualizare trimisă: | 03/03/2020 |
| Ultima actualizare postată: | 03/05/2020 |
| Data actuală de începere a studiului: | 01/31/2019 |
| Data estimată de finalizare primară: | 01/31/2021 |
| Data estimată de finalizare a studiului: | 01/31/2022 |
Stare sau boală
Intervenție / tratament
Other: Hypoxia
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Experimental: Hypoxia During each session, study participants will receive a single sequence of AIH, consisting of 15 x 60-seconds periods of hypoxia alternating with 90-seconds of normoxia (21% O2), for a total of 30 minutes, whilst in a seated upright position. AIH will be applied by directing gas flow to a reservoir bag connected via plastic tubing to a non re-breathing facemask/respiratory valve system while the participants are in a seated position. Defined gas mixtures will be delivered by manual adjustment of one-way valves attached to a hypoxia generator. | Other: Hypoxia An oxygen monitor will continuously measure and record the fraction of inspired oxygen delivered to the subject. Inspired fraction of oxygen (FiO2) of the gas mixture will be individually adjusted using the valve settings to reach the targeted SpO2. The gas mixtures administered during the four sessions will be 21% O2 (target SpO2 = 95%), 17% O2 (target SpO2 = 92%), 13% O2 (target SpO2 = 87%) and 9% O2 (target SpO2 = 82%). |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | All |
| Acceptă voluntari sănătoși | da |
| Criterii | Inclusion criteria: Age ≥18 years; A first time, unilateral, ischemic, hemispheric stroke, confirmed by magnetic resonance imaging (MRI); Chedoke assessment > 3 Ability to open and close affected hand Able to understand and communicate in English Be able to consent independently ≥ 6 months post stroke Must have a hemoglobin level above 10g/dl (to be confirmed using handheld noninvasive lab equipment) Must have ability to attend research visits with a companion for assistance WOCBP must be comfortable confirming negative pregnancy prior to hypoxia experimental therapy. Exclusion criteria: Brain stem or cerebellar stroke; mean Fazekas score rated on initial fluid-attenuated inversion recovery MRI ≥3 Severe aphasia, preventing subject from understanding the protocol and giving written consent; History of prior neurological disorder; Pre-existing hypoxic pulmonary disease, Severe hypertension (>160/100) Ischemic cardiac disease. |
Rezultat
Măsuri de rezultate primare
1. Clinical/neurological status over the duration of the study [6 days]
Măsuri de rezultate secundare
1. National Institute of Health Stroke Scale (NIHSS) [6 days]
2. Fugl- Meyer Assessment [6 days]
3. Modified Ashworth Scale [6 days]
4. Grip strength [6 days]
5. Pinch Strength [6 days]
6. Elbow strength [6 days]
7. D-KEFS Color-Word Interference Test [6 days]
8. 5 minute neurological test [6 days]
