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Online Sleep Program for Survivors of Gynecologic Cancers

N/A
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current sleep disturbance demonstrated by a Pittsburgh Sleep Quality Index (PSQI) score > 5
History of Stage I, II, or III gynecologic cancer
Must not have
History of a primary diagnosis of a distinct non-gynecologic or non-skin cancer other than a non-melanoma skin cancer within the 5 years prior to enrollment
Male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (part 1 and part 2 participants), immediately after the intervention (part 1 and part 2 participants), 3-months post-intervention (part 2 participants only)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether an online program can help gynecologic cancer survivors with insomnia.

Who is the study for?
This trial is for English-speaking gynecologic cancer survivors aged 18-74 with sleep issues, who finished their primary cancer treatment at least 30 days ago. They must have internet and phone access, and typically go to bed between 9 PM and 3 AM. Those with severe health conditions or on certain medications, other major cancers, or recent CBT-I therapy cannot join.
What is being tested?
The study tests three methods to improve sleep: limiting time in bed (sleep restriction), establishing a consistent sleep routine (stimulus control), and using light exposure strategically. The goal is to find effective treatments for sleep difficulties in women who've had gynecologic cancer.
What are the potential side effects?
Potential side effects are not specified but may include tiredness due to sleep restriction or discomfort adjusting to new routines. Light therapy can sometimes cause eye strain or headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have trouble sleeping, as shown by my PSQI score being over 5.
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I had Stage I, II, or III cancer of the female reproductive organs.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a non-skin, non-gynecologic cancer diagnosis in the last 5 years.
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I am male.
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I have significant difficulty thinking or doing physical activities.
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My condition is at stage IV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (part 1 and part 2 participants), immediately after the intervention (part 1 and part 2 participants), 3-months post-intervention (part 2 participants only)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (part 1 and part 2 participants), immediately after the intervention (part 1 and part 2 participants), 3-months post-intervention (part 2 participants only) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in objectively-measured sleep outcomes from baseline to immediately after the intervention and 3-months post-intervention
Changes in perceived impairment during wake associated with sleep problems from baseline to immediately after the intervention and 3-months post-intervention
Changes in subjectively-reported sleep quality from baseline to immediately after the intervention and 3-months post-intervention
Secondary study objectives
Changes in fatigue from baseline to immediately after the intervention and 3-months post-intervention
Changes in health-related quality of life (HRQOL) from baseline to immediately after the intervention and 3-months post-intervention
Changes in overall symptom burden from baseline to immediately after the intervention and 3-months post-intervention
+2 more
Other study objectives
Changes in circadian activity rhythms from baseline to immediately after the intervention and 3-months post-intervention
Changes in urinary 6-Sulfatoxymelatonin from baseline to immediately after the intervention and 3-months post-intervention

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Systematic light exposureExperimental Treatment1 Intervention
Group II: Stimulus control and Systematic light exposureExperimental Treatment2 Interventions
Group III: Stimulus controlExperimental Treatment1 Intervention
Group IV: Sleep restriction, Stimulus control, and Systematic light exposureExperimental Treatment3 Interventions
Group V: Sleep restriction and Systematic light exposureExperimental Treatment2 Interventions
Group VI: Sleep restriction and Stimulus controlExperimental Treatment2 Interventions
Group VII: Sleep RestrictionExperimental Treatment1 Intervention
Group VIII: Sleep trackingActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep restriction
2005
Completed Phase 1
~450

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,420 Total Patients Enrolled
3 Trials studying Insomnia
183 Patients Enrolled for Insomnia
University of ArizonaLead Sponsor
539 Previous Clinical Trials
161,581 Total Patients Enrolled
6 Trials studying Insomnia
372 Patients Enrolled for Insomnia
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,992 Total Patients Enrolled
11 Trials studying Insomnia
1,995 Patients Enrolled for Insomnia

Media Library

Sleep restriction Clinical Trial Eligibility Overview. Trial Name: NCT05044975 — N/A
Insomnia Research Study Groups: Stimulus control, Sleep Restriction, Sleep tracking, Sleep restriction, Stimulus control, and Systematic light exposure, Sleep restriction and Stimulus control, Sleep restriction and Systematic light exposure, Stimulus control and Systematic light exposure, Systematic light exposure
Insomnia Clinical Trial 2023: Sleep restriction Highlights & Side Effects. Trial Name: NCT05044975 — N/A
Sleep restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05044975 — N/A
~24 spots leftby Jan 2026
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