Insomnia in Patients With Metastatic Lung Cancer

Insomnia in Patients With Metastatic Non Small Cell Lung Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06472804

Enrollment

Registered

2024-06-25

Start date

2019-06-19

Completion date

2027-06-01

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

Brief summary

This study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer. OUTLINE: This is an observational study. Patients undergo medical chart review and complete a questionnaire on study.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have a diagnosis of metastatic non small cell lung cancer * Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy * Older than 18 years old at the time of diagnosis

Exclusion criteria

* Subjects will be excluded if they are considered to have advanced terminal cancer, severe depression or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing), regular use of psychotropic medication other than hypnotics (eg antidepressants) per chart review

Design outcomes

Primary

Measure	Time frame	Description
Frequency of clinically significant insomnia	Baseline	Will be assessed using the Insomnia Severity Index questionnaire (ISI), is a 7-item self-report questionnaire used to gauge the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. ISI score of 15 or greater will be used to categorize clinical insomnia. 0 - 7: no clinically significant insomnia, 8 - 14: subthreshold insomnia, 15 - 21: clinical insomnia (moderate severity), 22 - 28: clinical insomnia (severe).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKonstantinos Leventakos, M.D., Ph.D.

Mayo Clinic in Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026