CLINICAL TRIAL PHASE II, MULTICENTRIC, NATIONAL, DOUBLE-BLIND, PARALLEL, RANDOMIZED, AND PLACEBO-CONTROLLED FOR EVALUATION OF THE IMPROVEMENT OF SLEEP QUALITY IN PARTICIPANTS OF RESEARCH WITH INSOMNIA DISORDER

February 23, 2023 updated by: Fernando Morgadinho Santos Coelho, Federal University of São Paulo

QUALI-001 code Phase II. Multicentric type. Test Product (QUALI-50) and (QUALI-75). Control Placebo capsule Primary goal Evaluate the improvement in sleep quality through the evaluation comparison of Pittsburgh Sleep Quality Index Scale scores obtained in visit 04 (final) compared to visit 02.

Evaluate the impact of treatments on improving sleep quality and total sleep time through actigraphic evaluation obtained through the average of the data observed in the last 07 days of treatment, compared to the average of the data observed in the 07 days of the basal period.

Outcome: A significant reduction in the score on the Scale is expected Pittsburgh Sleep Quality Index.

A significant increase in sleep efficiency is expected and a significant decrease in sleep latency time and the number of arousals evaluated through actigraphy.

Design Multicenter, randomized, placebo-controlled, parallel, with three treatments, in which each patient will receive treatment.

Arm 01: Control Treatment: Sleep Hygiene + Basic Medications + Placebo Arm 02: Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system.

Arm 03: Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system.

Population Research participants of both sexes, diagnosed with Moderate or severe insomnia disorder.

Control Treatment: Sleep Hygiene + Basic Medications + Placebo Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system Reviews of efficiency Sleep quality scales, actigraphic measures, and sleep diary sleep. Reviews of security Clinical examination, monitoring of adverse events, electrocardiogram, and laboratory tests.

Criteria of Inclusion Agreement to participate in the study, documented through signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period.

Criteria of Exclusion Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain.

Research participants with a history of thyroid dysfunction significant or uncontrolled.

Taking the following CNS depressant drugs:

Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia.

Size of sample: Inclusion of approximately 99 research participants, divided into 3 parallel arms.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

QUALI-001 code Phase II. Multicentric type. Test Product (QUALI-50) and (QUALI-75). Control Placebo capsule Primary goal Evaluate the improvement in sleep quality through the evaluation comparison of Pittsburgh Sleep Quality Index Scale scores obtained in visit 04 (final) compared to visit 02.

Evaluate the impact of treatments on improving sleep quality and total sleep time through actigraphic evaluation obtained through the average of the data observed in the last 07 days of treatment, compared to the average of the data observed in the 07 days of the basal period.

Outcome: A significant reduction in the score on the Scale is expected Pittsburgh Sleep Quality Index.

A significant increase in sleep efficiency is expected and a significant decrease in sleep latency time and the number of arousals evaluated through actigraphy.

Design Multicenter, randomized, placebo-controlled, parallel, with three treatments, in which each patient will receive treatment.

Arm 01: Control Treatment: Sleep Hygiene + Basic Medications + Placebo Arm 02: Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system.

Arm 03: Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system.

Population Research participants of both sexes, diagnosed with Moderate or severe insomnia disorder.

Control Treatment: Sleep Hygiene + Basic Medications + Placebo Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system Reviews of efficiency Sleep quality scales, actigraphic measures, and sleep diary sleep. Reviews of security Clinical examination, monitoring of adverse events, electrocardiogram, and laboratory tests.

Criteria of Inclusion Agreement to participate in the study, documented through signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period.

Criteria of Exclusion Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain.

Research participants with a history of thyroid dysfunction significant or uncontrolled.

Taking the following CNS depressant drugs:

Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia.

Size of sample: Inclusion of approximately 99 research participants, divided into 3 parallel arms.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Agreement to participate in the study, documented through the signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period.

Exclusion Criteria:

Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain.

Research participants with a history of thyroid dysfunction significant or uncontrolled. Taking the following CNS depressant drugs: Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Estimate)

March 3, 2023

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Researcher)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Initiation and Maintenance Disorders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe