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Non-insomnia Group for Insomnia

N/A
Waitlist Available
Research Sponsored by SRI International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be post-pubertal
BMI <30 kg/m-2 to reduce the likelihood of obesity-related sleep-disordered breathing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions)
Awards & highlights

Study Summary

This trial looks at how well a new treatment for insomnia works in teenagers.

Eligible Conditions
  • Insomnia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average nocturnal Pre-ejection period (PEP), as a measure of cardiac sympathetic activity
Average nocturnal heart rate (HR), as a measure of cardiac contractility

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-insomnia GroupExperimental Treatment3 Interventions
Non-insomnia participants will not meet criteria for current DSM-5 Insomnia Disorder or have a past history of insomnia. Interventions (order is randomly assigned): no pre-sleep arousal manipulation night; pre-sleep arousal down-regulation night pre-sleep arousal up-regulation night.
Group II: Insomnia GroupExperimental Treatment3 Interventions
Insomnia Group participants will have to meet DSM-5 criteria for current Insomnia Disorder. Interventions (order is randomly assigned): no pre-sleep arousal manipulation night; pre-sleep arousal down-regulation night pre-sleep arousal up-regulation night.

Find a Location

Who is running the clinical trial?

SRI InternationalLead Sponsor
16 Previous Clinical Trials
9,575 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to become a participant in this clinical trial?

"For admittance to this research program, people must be aged between 16 and 20 years old and present with a sleep disorder. 110 participants are being admitted in total."

Answered by AI

What is the scope of involvement in this medical trial?

"Affirmative. Clinicaltrials.gov confirms that this medical study, initially posted on January 7th 2019, is actively recruiting patients. 110 participants must be selected from 1 clinical centre for the trial to proceed."

Answered by AI

Are any individuals of a mature age being sought for recruitment in this experiment?

"The criteria for enrollment in this clinical trial specify that all participants must be between 16 and 20 years old."

Answered by AI

Is recruitment for this trial open at the present time?

"Affirmative. As indicated on clinicaltrials.gov, this medical research project is actively seeking participants. First posted in July of 2019 and last updated in May 2022, the study requires 110 test subjects from a single site to be enrolled."

Answered by AI
~19 spots leftby Mar 2025