Clinical trial NCT02323464: Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer
Official title: Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Sleep Apnea Syndromes
Hypoxia
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for surgery of colorectal cancer Healthy volunteers from population based studies will be included as controls

Brief summary: 212 patients with colorectal cancer will be investigated before surgery and 100 of them after surgery. 597 individuals from a previous population based study will serve as controls to the prevalence of sleep apnea in the general population.

Investigations will include polysomonographic sleep apnea recordings during one night, lung function measurements, blood gas samples and questionnaires.

Controls: Men and women from two population-based cohort studies

Detailed description: Inclusion: 212 patients with colorectal cancer will be investigated before surgery and 100 of them will also be investigated in the same manner after surgery. Due to drop-outs we calculate a need of inviting at least 250 patients.

Controls: 597 individuals from a previous population based study will serve as controls to the prevalence of sleep apnea in the general population.

Exclusion: Dementia, CPAP treated sleep apnea investigations: Patients are investigated with lung function, blood-gas samples, questionnaires, overnight polysomnographic sleep apnea recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.

Controls: Men and women from two population-based cohort studies the "Sleep and health in women" and the "Men in Uppsala: A Study of Sleep, Apnea and Cardiometabolic Health" and older men and women from a local senior organization.

Outcomes: Prevalence of sleep apnea and hypoxia, sleep quality, and lung function, blood gas, STOP-BANG, Epworth sleepiness scale, Mallampati score, symptoms of sleep apnea, surgical complications, mortality, cancer severity.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgery of colorectal cancer

Exclusion Criteria:

* Dementia, CPAP treatment for obstructive sleep apnea

Primary outcomes:
measure: Prevalence of sleep apnea
timeFrame: 1 week
Secondary outcomes:
measure: Sleep quality
timeFrame: 1 week
measure: hypoxia, hypercapnia
timeFrame: 1 week
measure: lung function
timeFrame: 1 week
measure: subjective sleepiness
timeFrame: 1 week
measure: Mortality
timeFrame: Until death
measure: Side effects of surgery
timeFrame: 30 days
measure: Severity of cancer
timeFrame: 30 days
measure: nocturnal hypoxia
timeFrame: 1 week
measure: Mallampati score
timeFrame: 1 day
measure: STOP-Bang
timeFrame: 1 week
measure: Symptoms of sleep apnea
timeFrame: 1 month
measure: Sex differences
timeFrame: 1 month
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of Surgery, Inst of Surgical and Perioperative sciences
state: Umea
Study officials:
affiliation: Dept of Surgical and perioperative sciences, Umeå University
name: Kar A Franklin, Ass prof
role: PRINCIPAL_INVESTIGATOR
References: