An interventional study of white noise and usual care in Sleep Deprivation, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-01.
Sponsored by Yale University · Not applicable, Interventional, and Supportive care
A feasibility study to evaluate the use of white noise to improve sleeping conditions in an ICU setting.
The ICU is full of alarms and critically ill patients, so it is no surprise that sleep is very much fragmented and poor in this setting, as documented in numerous studies. White noise is a simple intervention that has been shown to improve sleep, including in the ICU setting. The aim is to conduct a pilot trial evaluating the feasibility of providing white noise to patients in the ICU at night to help improve sleep. The plan to measure feasibility metrics including patient acceptance, patient tolerance, and intervention fidelity; also to seek feedback from patients, nurses, and providers. Secondly is to evaluate the benefits of providing white noise at night in the ICU on sleep as measured by actigraphy and Richards-Campbell Sleep Questionnaires and total room sound.
308 studies on the registry are indexed under Sleep Deprivation; 62 are open to participants now.
This study's enrollment of 7 is below the median of 44 across 253 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Six patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined; pausing will be at nurse, provider, and patient discretion during routine care and conversations with the patients.
Device: white noise
Six patients exposed to normal ICU activity noise.
Behavioral: usual care
Patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined.
normal ICU activity noise
Intervention fidelity: percent of intervention time during which white noise is actually delivered
percent of intervention time during which white noise is actually delivered
Time frame: 48 hours
Sound Levels
Room dBA and dBC-weighted sound levels will be measured in the rooms as well by HD600 sound meters (Extech Instruments) every 10 seconds throughout the night shift; sound meters will be placed on the wall behind and 10" above the head of the bed (set when head of bed is at 30 degrees).
Time frame: 48 hours
Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires.
Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires. Scores will be graded on a scale of 0-100, as measured in mm on the visual scale; 100 representing a more positive sleep experience.
Time frame: 48 hours
Actigraphic rest-activity :Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.
Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.
Time frame: 48 hours
Patient tolerance: percent of days that patients agree to continue white noise
percent of days that patients agree to continue white noise
Time frame: 48 hours
Patient acceptance: percent of patients or surrogates who agree to receive white noise at night
percent of patients or surrogates who agree to receive white noise at night
Time frame: 48 hours
Ran from Nov 2018 to primary completion in Mar 2019, 3 months.
Of 142 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's 3 months is below that.
Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 8 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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