MedDataX Logo

Sleep Subtypes in Adolescent Depression

NCT ID: NCT03742960

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2023-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare sleep neurophysiology and behavior in adolescents with MDD with hypersomnia (MDD-HYP) and insomnia (MDD-INS) with healthy controls (HC). In addition, the investigators will test the efficacy of a simple behavioral sleep restriction on mood and sleep in their sample.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The World Health Organization has identified depression as the leading cause of burden of disease amongst young people. Subjective sleep complaints are often a core symptom of depression and highly prevalent with 60-90% of depressed adolescents suffering from disrupted sleep. This sleep disruption often takes the form of insomnia (e.g., difficulty falling or staying asleep, or waking too early) or hypersomnia (prolonged sleep episodes or excessive daytime sleepiness). The aim of the trial is to examine the efficacy of a simple behavioral sleep restriction two weeks in duration on mood and sleep in adolescents ages 14 to 17 years with and without major depressive disorder. During this period sleep is objectively measured using actigraphy and monitor mood using self-report. The results of the study will inform whether a simple behavioral sleep restriction beneficially impacts mood and sleep.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Behavioral Sleep Restriction

Participants will be required to go to sleep half an hour later than their usual bedtime. Wake up time will be determined via their usual wake time.

Group Type EXPERIMENTAL

Behavioral Sleep Restriction

Intervention Type BEHAVIORAL

Participants will be instructed to go to bed 30 minutes later than their usual bedtime. On the other hand, wake up time will be unchanged resulting a nightly sleep restriction of 30 minutes. This protocol will be followed for two weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Sleep Restriction

Participants will be instructed to go to bed 30 minutes later than their usual bedtime. On the other hand, wake up time will be unchanged resulting a nightly sleep restriction of 30 minutes. This protocol will be followed for two weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- This study will recruit adolescents (ages 14 to 17 years) with major depressive disorder (MDD) with insomnia (MDD-INS) and with hypersomnia (MDD-HYP) and age and gender matched controls (HC).



* MDD as determined through the MINI-KID
* Determination of hypersomnia as defined by excessive daytime sleepiness, or long sleep duration.
* Written informed consent


* MDD as determined through the MINI-KID
* Determination of insomnia as defined by the insomnia severity index
* Written informed consent

Exclusion Criteria

* Current or lifetime experience of frank psychosis or mania
* Presence of suicidal intent representing imminent risk as indicated during clinical interview
* Medical or neurological condition that could impact brain functioning
* History of physical brain injury or blow to the head resulting in loss of consciousness greater than 5 minutes
* Do not meet criteria for substance or alcohol dependence in the last three months
* Presence of an organic sleep disorder (e.g., narcolepsy, sleep apnea)


* Presence of psychiatric disorder
* Self-reported disrupted, short or ill-timed sleep


• No sleep difficulties
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital for Child and Adolescent Psychiatry and Psychotherapy Bern

UNKNOWN

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Leila Tarokh, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Leila Tarokh

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Sleep Subtypes

Identifier Type: -

Identifier Source: org_study_id