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Primary Insomnia clinical trials

View clinical trials related to Primary Insomnia.

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NCT ID: NCT01489969 Completed - Primary Insomnia Clinical Trials

Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients

Start date: December 2011
Phase: Phase 2
Study type: Interventional

This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia patients aged 18-80 years, following the first two nights (immediate effect) and at the end of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The secondary endpoints are number of awakenings after sleep onset and the duration of wake after sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings).

NCT ID: NCT01286324 Completed - Chronic Insomnia Clinical Trials

Chamomile for Chronic Primary Insomnia

Start date: July 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if an herb called chamomile can help to treat insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of time that you sleep and/or improving the quality of your sleep. The study will also be looking at the effect of chamomile on day time fatigue and functioning.

NCT ID: NCT01181232 Completed - Clinical trials for Sleep Initiation and Maintenance Disorders

A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients

Start date: October 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.

NCT ID: NCT01097629 Completed - Primary Insomnia Clinical Trials

Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)

Start date: May 3, 2010
Phase: Phase 3
Study type: Interventional

This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep.

NCT ID: NCT01097616 Completed - Primary Insomnia Clinical Trials

Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)

Start date: May 5, 2010
Phase: Phase 3
Study type: Interventional

This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase.

NCT ID: NCT01021852 Completed - Primary Insomnia Clinical Trials

Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)

Start date: November 30, 2009
Phase: Phase 2
Study type: Interventional

This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and effectiveness of different doses of MK-6096 in the treatment of participants with primary insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of 4 weeks of treatment (Week 4).

NCT ID: NCT01006525 Completed - Primary Insomnia Clinical Trials

Safety and Efficacy of Chronic Hypnotic Use

Start date: December 2005
Phase: N/A
Study type: Observational

The purpose of the study is to determine how safe and effective it is for people with insomnia to use zolpidem on a nightly basis for one year.

NCT ID: NCT00956319 Completed - Clinical trials for Sleep Initiation and Maintenance Disorders

A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients

Start date: May 2009
Phase: Phase 4
Study type: Interventional

The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.

NCT ID: NCT00878553 Completed - Sleep Disorder Clinical Trials

Study of Sleep-maintenance Activity of 3 Doses of SKP-1041

Start date: May 2010
Phase: Phase 2
Study type: Interventional

SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings.

NCT ID: NCT00855140 Completed - Primary Insomnia Clinical Trials

Acupuncture for the Treatment of Insomnia

Start date: March 2009
Phase: N/A
Study type: Interventional

Insomnia is a common and disabling condition associated with psychiatric and medical comorbidities and often persists despite currently available treatments. Acupuncture has been reported to benefit individuals with insomnia and can decrease hyperarousal. This blinded RCT will investigate the impact of a standardized acupuncture protocol on insomnia, daytime symptoms, and hyperarousal.