Clinical trials: Sleep Disturbances and Insomnia
Chronic Insomnia
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia
- Trial name
- NCT02236845
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Lacrima Medical LTD
Insomnia
Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions
The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions using a single-dose, randomized, 2-treatment…
- Trial name
- NCT00601666
- Testing
- Zolpidem
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Primary Insomnia
Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia
The objective of this study is to determine the efficacy of a portable biofeedback device on improving sleep latency and other sleep variables such as nocturnal awake time and daytime functioning in persons with primary insomnia.
- Trial name
- NCT00415714
- Testing
- Portable Biofeedback
- Where
- United States
- Volunteers
- 132 people
- Sponsor
- Helicor
Insomnia Disorder
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.
- Trial name
- NCT02839200
- Testing
- ACT-541468 5 mg, ACT-541468 10 mg, ACT-541468 25 mg
- Where
- 35 sites in United States, Germany and 4 more
- Volunteers
- 360 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Pain, Osteoarthritis, Hip
Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee…
- Conditions
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- Trial name
- NCT00980798
- Testing
- OROS hydromorphone HCl
- Where
- 12 sites in Czechia, Romania and 2 more
- Volunteers
- 288 people
- Sponsor
- Janssen-Cilag International NV
Excessive Sleepiness, Shift-work Disorder
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and…
- Trial name
- NCT06568367
- Testing
- Solriamfetol 150 mg, Solriamfetol 300 mg
- Where
- 49 sites in United States, Canada
- Volunteers
- 520 people
- Sponsor
- Axsome Therapeutics, Inc.
Insomnia
Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia
The objective of the clinical investigation is to assess the performance of the Dreem 3 System for sleep assessment compared to a FDA-cleared PSG assessment and human sleep expert scoring in a population experiencing insomnia…
- Trial name
- NCT05438017
- Testing
- Dreem 3 System vs PSG
- Where
- 2 sites in United States, France
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dreem
Attention Deficit Hyperactivity Disorder
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of…
- Trial name
- Zolkids (NCT00318448)
- Testing
- Zolpidem (SL800750)
- Where
- 2 sites in United States, Canada
- Volunteers
- 201 people
- Sponsor
- Sanofi
Tension Headaches, Stress
Temple Massager System Study in Women Ages 35-65
The goal of this observational study is to learn how the Temple Massager System affects stress, emotional wellbeing, sleep, and quality of life in women aged 35 to 65.
- Conditions
- Tension Headaches, Stress, Sleep Quality, Quality of Life
- Trial name
- NCT07639658
- Testing
- Temple Massager System
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Meisch Temple Massager, Inc.
Insomnia Disorders
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users
The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and…
- Trial name
- NCT03158025
- Testing
- Zolpidem tablets, Suvorexant tablets, over-encapsulated, Lemborexant tablets
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Sleep Initiation and Maintenance Disorders
A Study of LY2624803 in Japanese Participants With Transient Insomnia
The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy Japanese participants. The study has four treatment periods.
- Trial name
- NCT01784614
- Testing
- LY2624803 - Solution, LY2624803 - Capsule
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Insomnia
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia
The primary objective of the study is to evaluate the safety and tolerability of Neu-P11, following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching placebo) given nightly over 2 periods of 5 days…
- Trial name
- NCT01114126
- Testing
- Neu-P11
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Jet Lag Disorder, Jet Lag
A Study on the Effectiveness of a Dietary Supplement FitoAvia for Jet Lag
Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony Objectives of the study: 1. Assessment of the condition of patients with jet lag of 4 hours or more 2.
- Conditions
- Jet Lag Disorder, Jet Lag, Jet Lag Type Insomnia, Cognition Improvement
- Trial name
- NCT07695870
- Testing
- Fitoavia, Questionnaire and Physical Exam, cognition tests
- Where
- Russia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- MiraxBioPharma
Insomnia Disorder
Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder
The main purpose of this study is to assess efficacy of YZJ-1139 for 28 days in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
- Trial name
- NCT06975514
- Testing
- YZJ-1139, Zolpidem
- Where
- 16 sites in China
- Volunteers
- 61 people
- Sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
IBS - Irritable Bowel Syndrome, Depression, Anxiety
The Impact of a Combination of Bifidobacterium Longum 35624® and 1714™ Strains in Adults With Irritable Bowel Syndrome
This study aimed to assess the impact of consumption of COMBO, a combination product of two Bifidobacterium longum strains, on stress, mood and bowel symptoms in adults with Irritable Bowel Syndrome (IBS).
- Trial name
- IBS (NCT04422327)
- Testing
- Probiotic capsule
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- PrecisionBiotics Group Ltd.
Primary Insomnia
Comparison of Two Temperatures to Treat Insomnia
Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia patients.
- Trial name
- NCT01790256
- Testing
- Cereve Sleep System at 30 degrees C, Cereve Sleep System at 14-16 degrees C
- Where
- 9 sites in United States
- Volunteers
- 144 people
- Sponsor
- Cereve, Inc.
Insomnia
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of YZJ-1139 in Healthy Participants
Primary Objective： 1. To evaluate the tolerability, safety of single and multiple doses of YZJ-1139 in healthy participants 2. To evaluate the pharmacokinetic of single and multiple doses of YZJ-1139 in healthy participants…
- Trial name
- NCT06673927
- Testing
- YZJ-1139
- Where
- China
- Volunteers
- 104 people
- Sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Skin Ageing, Healthy Ageing
Effects of a Multi-Targeted Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido and Epigenetic Biological Clock Age
This study evaluated the effects of a daily oral supplement regimen (Advanced ID Brain, Heart and Eye Omega Gel Capsules taken with Advanced ID Longevity and Collagen Complex Powder) on measures of skin condition, hair, sleep…
- Conditions
- Skin Ageing, Healthy Ageing, Effect of Oral Nutritional Supplementation on Skin, Hair, Sleep, Energy, Cognition and Sexual Wellbeing in Healthy Adults, Longevity
- Trial name
- IDF-AID-1 (NCT07827651)
- Testing
- Advanced ID
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- IDI Skincare Limited
Insomnia, Insomnia Type; Sleep Disorder
Evaluation Of The Diamine Oxidase Supplementation Effect In Patients With Insomnia Symptoms
Considering the high prevalence of DAO enzyme deficiency in patients referring insomnia symptoms, it would be plausible that the appearance of insomnia symptoms were explained by the DAO enzyme deficiency.
- Trial name
- DAO-SLEEP-2023 (NCT07027943)
- Testing
- DAO supplement
- Where
- Spain
- Volunteers
- 108 people
- Sponsor
- AB Biotek
Insomnia
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
- Trial name
- NCT00506389
- Testing
- Esmirtazapine
- Volunteers
- 419 people
- Sponsor
- Merck Sharp & Dohme LLC