Phase 3 Sleep Disorders Trial, Recruiting NCT05474846 Sponsor: M.D. Anderson Cancer Center Condition: Sleep Disorders
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Phase 3 Sleep Disorders Trial, Recruiting

NCT05474846
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have had poor sleep quality for at least 2 weeks, with a score of 5 or higher on a standard sleep quality questionnaire called the PSQI
  • People who are able to communicate in English
  • People who are mentally alert enough to answer questions clearly, as measured by a standard assessment tool (confirm with trial site)
  • People who are willing and able to sign a written consent form
  • People whose cancer specialist or the lead researcher has estimated they are likely to live for at least another year
  • People who have no pain, or whose pain is well-controlled and stable — meaning pain is rated 4 or below on a standard symptom scale, or they have been on a steady dose of pain medication for at least 1 month
  • People aged 18 years or older
  • People who are willing to attend follow-up visits either in person or by video call, and who are able to complete the therapy sessions (either in person or online) within the state of Texas

Who may not be able to join:

  • People who are currently taking prescription anti-inflammatory medications or steroids, unless those medications were used specifically to prevent side effects during or before cancer treatment (such as for nausea)
  • People with a known history of certain mental health conditions (such as schizophrenia, bipolar disorder, or major depressive disorder), certain sleep disorders (such as sleep apnea, narcolepsy, or periodic limb movement disorder), obesity-related breathing problems during sleep, glaucoma, blindness (present from birth or acquired), significant cataracts or retinal disease, or people who regularly work night shifts
  • People who score 21 or higher on an anxiety and depression questionnaire, or who are taking antidepressants — unless they have been on a stable dose of antidepressants for at least 1 month
  • People who are currently taking sleep medications or stimulants, unless they have been on a stable dose of those medications for at least 1 month
  • People who are taking certain types of medications, including a group called MAO inhibitors, tricyclic antidepressants, or blood thinners
  • People who have spent 30 or more consecutive minutes in bright sunlight every day over the past month, or who have previously tried bright light therapy, melatonin-related treatments, or a type of talking therapy called CBT for sleep
  • People whose doctor (the lead researcher) determines there is another medical reason that would make participation risky
  • People taking part in the brain scan (MRI) part of the study who have any metal objects in their body (such as metal plates, certain dental braces, or a heart pacemaker), or who experience claustrophobia (fear of enclosed spaces)
  • People who are pregnant, as recorded in their medical record

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Sriram Yennu, MD, MD Anderson

Phone: 713-792-6085

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
21 November 2022
Est. completion
28 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pittsburgh Sleep Quality Index (PSQI) questionnaires

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov