Sleep Bruxism

Sleep Disorder

Psychosomatic Disorder

Pain

Anxiety

Mental Status Change

Temporomandibular Disorder

Each of the patients will undergo polysomnography

Polysomnography

Wroclaw Medical University

Relationship Between Selected Parameters and Bruxism

Assessment of Sleep Structure, Selected Blood Parameters, Respiratory Function, Genotype, Phenotype, Pain, Anxiety and Psychosomatization in Patients With Bruxism

Polysomnograms will be evaluated in a 30-second contributions, according to standard sleep criteria. PSG results will contain data on the latency of sleep, total sleep time (TST), sleep efficiency (%) and an evaluation of phases N1, N2, N3 and REM.

Each participant will fill in Insomnia Severity Scale. Questionnaire contains 5 questions, scored from 0 to 4 depending on the severity of ailments. Minimal score is 0, maximal score is 20. A total point value of up to 10 is considered the norm, while a score above 14 points indicates clinically significant insomnia.

Each participant will fill in KPS sense of stress questionnaire. The questionnaire consists of 27 statements; the subject determines the extent to which the statement relates to him using a five-point scale. It allows you to calculate the overall score of generalized stress levels, as well as three results related to the following dimensions: emotional tension, external stress and intrapsychic stress. The questionnaire also contains the scale of lies.

Each participant will fill in Traumatic Experience Checklist comprising 29 different traumatic experiences. It assesses 5 types of trauma and 4 types of problems: emotional neglect, emotional abuse, body threat, sexual harassment, and sexual abuse, serious family problems , death or loss of a family member, body harm, and war experiences. Scoring includes computing two indexes (overall index of number of traumas experienced resulting from the sum of all items, and the total area of traumatic presence which is the sum of the 5 traumatic experiences areas); and three trauma severity indexes (determined by the impact of trauma and age when it occurred, and assembled into emotional, physical, and sexual trauma). The severity of total trauma can range from 0 to 13 (neglect and emotional abuse, physical abuse, and sexual harassment or abuse) or from 0 to 24 (body threat, pain, and bizarre/strange punishment).

Each participant will fill in mini COPE. Questionnaire consists of 28 statements that make up 14 stress coping strategies.Some testing strategies were divided into four categories and corresponding strategies (inventory scales): active coping (including: active coping, planning, positive reevaluation), helplessness (including: taking psychoactive substances, cessation of actions, blaming self), seeking support (including: seeking emotional support, seeking instrumental support), avoidance behaviors (including dealing with something else, denying, discharging). three strategies create independent factors (turning to religion, acceptance, sense of humor). The range of results for each statement ranges from 0 to 3 points. The calculation of the results consists in adding to each other points for the answers regarding two theorems that make up the given scale, and then dividing by 2.

Each participant will fill in Courtauld Emotional Control Scale that consists of three subscales, each of them containing seven statements regarding the way of showing anger, depression, and anxiety. The scale is used to measure subjective control of anger, anxiety, and depression in difficult situations and designed to examine adults (both healthy and ill). CECS is a tool of self-description. Summing up the scores of all three subscales, the overall score of emotion control is established. The examination aims at defining to what degree an individual is convinced subjectively of ability to control his/her reactions in the situation of experiencing given negative emotions. The overall indicator of emotion control is within the range of 21-84 points. The higher the score, the greater the suppression of negative emotions.

Each participant will fill in Accteptance of Illness Scale. The scale is used to measure the degree of acceptance of the disease. It contains eight statements describing the negative consequences of poor health. Each statement is scored from 1 to 5, where 1 means strongly agree and 5 strongly disagree. The scale has no standards. The obtained result is compared with the average result of one of eight clinical groups. The scale is used to measure the degree of disease acceptance. It can apply to any disease. The greater the acceptance of the disease, the better the adaptation and the less sense of mental discomfort.

Each participant will fill in Beck Anxiety Index. The total score is calculated by finding the sum of the 21 items. Total score for all 21 symptoms that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe".

Each participant will fill in IPIP-BFM 20. The questionnaire measures five traits (Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Intellect), and consists of 20 items.

Each participant will fill in McGill questionnaire that is composed of 78 words. Respondents choose those that best describe their experience of pain. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).

Each participant will fill in Graded Chronic Pain Scale. Scoring Criteria for Grading Chronic Pain Severity: Characteristic Pain Intensity is a 0 to 100 score derived from Questions 1 through 3:Mean (Pain Right Now, Worst Pain, Average Pain) X 10. Disability Score is 0 to 100score derived from Questions 4 through 6:Mean (Daily Activities, Social Activities, Work Activities) X 10. Disability Points: Add the indicated points for Disability Days (Question 7)and for Disability Score. Classification: GRADE 0- No TMD pain in prior 6 months. GRADE I-Low Intensity Characteristic Pain Intensity<50, Low Disability<3 Disability Point. GRADE II -High Intensity Characteristic Pain Intensity >50, LowDisability<3 Disability Points. GRADE III- High Disability3 to 4 Disability Points, Moderately Limiting (Regardless of Characteristic Pain Intensity). GRADE IV- High Disability 5 to 6 Disability Points, Severely Limiting (Regardless of Characteristic Pain Intensity).

Each participant will fill in Patient Health Questionnaire - 9. PHQ-9 total score for the nine items ranges from 0 to 27.Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

Each participant will fill in Pittsburgh Sleep Quality Index. The measure consists of 19 individual items, creating 7 components that produce one global score ranging from 0 to 21, where lower scores mean better sleep quality.

Each participant will fill in STOP-Bang questionnaire. The total score ranges from 0 to 8. The lower the score is, the lower the risk of occurrence Obstructive Sleep Apnea (OSA).

Each participant will fill in Beck Depression Inventory. The questionnaire is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The minimum total score is 0, the maximum total score is 63. Enables scoring: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression.

Each participant will fill in Perceived Stress Scale -10. Scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. It can range from 0 to 40. Scores ranging from 0-13 would be considered low stress,14-26 would be considered moderate stress, 27-40 would be considered high perceived stress.

Each participant will fill in Headache Impact Test - 6 . These responses are summed to produce a total score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent.

Each participant will fill in Generalized Anxiety Disorder -7 that consists of 7 items. Total score ranges 0-21 points. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Each participant will fill in Migraine Disability Assessment questionnaire. Scoring includes adding the total number of days from questions 1-5. Grading includes: grade I (little or no disability) 0-5 days, grade II (mild disability) 6-10 days, grade III (moderate disability) 11-20 days, grade IV (severe disability) more than 21 days.

Each participant will undergo genetical blood test.

Joanna Smardz

Principal Investigator

Baseline data on neonatal encephalopathy and epilepsy before the introduction of the care bundle

Baseline data on neonatal encephalopathy and epilepsy after the introduction of the care bundle

Neonatal Encephalopathy

Epilepsy

Newborn Morbidity

Intra-partum care bundle invoking 4 elements

Institute of Obstetrics and Gynaecology

Bangalore Medical College

Calicut Medical College

Sudhin Thayyil

Prevention of Epilepsy by Reducing Neonatal Encephalopathy

Two of more unprovoked seizures at least 24 hours apart

Moderate or severe neonatal encephalopathy

Definite or probable seizures as per ILAE classification

Significant basal ganglia, cortical or white matter injury

Thayyil, Sudhin

University College, London

University of Oxford

University of Manchester

Madras Medical College

Bangalore Medical College and Research Institute

Government Medical College, Kozhikode

Magnetic resonance biomarkers will be quantified masked to the interventional group

intrathecal 2.5 ml of heavy bupivicaine 0.5% pulse 0.5 mg morphine and will receive intravenous dexmedetomidine infusion as prepared. Dexmedetomidine will be diluted to a volume of 50 ml (4 mg ml-1) and presented as coded syringes by an anesthesiologist. I.V. bolus of dexmedetomidine 1 ug kg-1 administered by a syringe pump over a 10-min period followed by an infusion of 0.4 ug kg-1h-1 dexmedetomidine during the surgery. Just after intrathecal injection, all drugs were infused intravenously. The infusions will be stopped at the end of surgery.

intrathecal2.5 ml of heavy bupivicaine 0.5% pulse 0.5 mg morphine and dexmedetomidine (10µg) and will receive an equal volume of saline intravenously

intrathecal 2.5 ml of heavy bupivicaine0.5% pulse 0.5 mg morphine and will receive an equal volume of saline intravenously

Postoperative Shivering

intrathecal block will be performed in sitting position using 25 G spinal needle at either the L3-L4 or L4-L5 intervertebral spaces.

intrathecal

Assuit University

Efficacy of Intrathecal Versus Intravenous Dexmedetomidine for Prevention of Post Spinal Anesthesia Shivering

Efficacy of Intrathecal Versus Intravenous Dexmedetomidine for Prevention of Post Spinal Anesthesia Shivering in Patients Undergoing TURP

Shivering will be assessed by Crossley and Mahajan scale where 0= No shivering, 1= Cyanosis and piloerection, 2 = Visible tremors only in one muscle group, 3 = Visible tremors in more than one muscle group, and 4 = intense shivering, tremors of the head, arm.

a 5- point scale: 1 = fully awake and oriented, 2 = drowsy, 3 = eyes closed but open on command, 4 = eyes closed but open to mild physical stimulation, and 5 = eyes closed and unresponsive to mild physical stimulation

hypotension, bradycardia, itching, nausea, vomiting

Shereen Mamdouh

Lecturer of anesthesia, ICU and pain managment

Assiut University

In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.

In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.
Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject.

All Subjects

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Birth weight in grams was obtained from medical records

Birth Weight

Information regarding the fraction of inspired oxygen (FiO2) was obtained along with the mode of assisted ventilation (nasal cannula, CPAP, non-invasive ventilation etc.)

Oxygen use

Information was obtained from medical charts for caffeine use

Caffeine use

The total number of apneas/breathing pauses will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).

No Vibration

Vibration

Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention

The total number of intermittent hypoxic episodes to <90% (pulse oximetry) lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).

Change in the Total Number of Intermittent Hypoxic Episodes to <90% Lasting >5 Seconds/Episode During the Intervention and Without Intervention

The total number of bradycardia episodes to <100 bpm lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).

Change in the Total Number of Bradycardia Episodes (<100 Beats Per Minute (Bpm), at Least 5 Seconds Long) During Intervention and Without the Intervention

Overall Study

Dr. Kalpashri Kesavan

Apnea of Prematurity

Hypoxia

Bradycardia

A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject.

Ronald Reagan Medical Center - UCLA

Santa Monica UCLA Mecial Center

Non-invasive Intervention for Apnea of Prematurity

Neuromodulation of Limb Proprioceptive Afferents Using a Vibratory Device to Decrease Apnea, Intermittent Hypoxia and Bradycardia of Prematurity.

Available online as supporting information:
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0157349#sec019

Kalpashri Kesavan

Clinical Instructor

University of California, Los Angeles

In the same subject there were 2 periods:
Arm 1. 'No intervention' period (no vibrations) - two 6 hour epochs - total of 12 hours of 'No intervention' Arm 2. Experimental period (with vibrations) - two 6 hour epochs - total of 12 hours of 'vibration intervention'
In the same subjects cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the experimental period (vibration) and druing the no intervention period (no vibration).

4 weeks of treatment before video-EEG monitoring

Ictal/Post-ictal Hypoxemia

Fluoxetine 20 mg per day during 4 weeks prior to video-EEG, then continued during video-EEG.
At the end of video-EEG, and according to patient's decision, treatment was either progressively withdrawn (1 week at 10 mg per day and then 1 week at 5 mg per day), or replaced by fluoxetine 20 mg open-label.

fluoxetine 20 mg

Placebo 20 mg per day during 4 weeks prior to video-EEG, then continued during video-EEG.
At the end of video-EEG, and according to patient's decision, treatment was either progressively withdrawn (1 week at 10 mg per day and then 1 week at 5 mg per day), or replaced by fluoxetine 20 mg open-label.

placebo 20 mg

Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique

Efficacy of Fluoxetine Against Seizure-induced Central Apneas

Efficacy of Fluoxetine Against Seizure-induced Central Apneas : a Randomized Placebo-controled Double-blind Trial.

Percentage of patients with at least one seizure associated with ictal/post-ictal SpO2 <90% in the group treated with fluoxetine compared to that receiving placebo.

Changes in score of BDI-II after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

Changes in score of NDDIE after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

Changes in seizure frequency after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

Changes in score of SASDQ after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

Changes in score of EPWORTH after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

Change in score of QOLIE-89 after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

Hospices Civils de Lyon

A single dose of 1 ml of naloxone (i.e 0.4 mg) or placebo will be administered by the supervising nurse or physician, using direct intravenous injection with a 5 ml syringe through peripheral venous catheter of which all patients will be equipped throughout the video-EEG.
The evolution from a partial seizure to a GTCS being gradual, and the total duration of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course of the seizure. Given the assumptions about the role of endogenous opioids release in the spontaneous termination of seizures, naloxone will be administrated immediately after the end of the GTCS and not before. Specifically, treatment administration will be performed within the 2 minutes following the end of the GTCS.

naloxone

Placebo will be isotonic sodium chloride which preparation in 1 ml vials will be centralized by the pharmaceutical department of Edouard Herriot Hospital to ensure its indistinguishability from naloxone A single dose of 1 ml of naloxone (i.e 0.4 mg) or placebo will be administered by the supervising nurse or physician, using direct intravenous injection with a 5 ml syringe through peripheral venous catheter of which all patients will be equipped throughout the video-EEG.
The evolution from a partial seizure to a GTCS being gradual, and the total duration of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course of the seizure. Given the assumptions about the role of endogenous opioids release in the spontaneous termination of seizures, naloxone will be administrated immediately after the end of the GTCS and not before. Specifically, treatment administration will be performed within the 2 minutes following the end of the GTCS.

Placebo

Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies Hôpital Neurologique

Efficacy of Naloxone in Reducing Postictal Central Respiratory Dysfunction in Patients With Epilepsy

st, 3rd, 5th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated
nd, 4th, 6th, etc seizure: Standard practice (O2 only in post-ictal period).

st, 3rd, 5th, etc seizure: Standard practice (O2 only in post-ictal period).
nd, 4th, 6th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated

tonic/hypoxia