Sleep Deprivation
Conditions
Brief summary
A feasibility study to evaluate the use of white noise to improve sleeping conditions in an ICU setting.
Detailed description
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.
Interventions
DEVICEwhite noise
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.
BEHAVIORALusual care
normal ICU activity noise
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults \>18yo admitted to MICU with expected stay of at least two nights after enrollment
Exclusion criteria
* Excluding intubated patients (so communication can be better) and patients on high-flow nasal cannula (which is already high background noise). * Patients who are on therapeutic hypothermia or are on comfort measures only will also be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention fidelity: percent of intervention time during which white noise is actually delivered | 48 hours | percent of intervention time during which white noise is actually delivered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sound Levels | 48 hours | 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). |
| Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires. | 48 hours | 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. |
| 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. | 48 hours | Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture. |
| Patient tolerance: percent of days that patients agree to continue white noise | 48 hours | percent of days that patients agree to continue white noise |
| Patient acceptance: percent of patients or surrogates who agree to receive white noise at night | 48 hours | percent of patients or surrogates who agree to receive white noise at night |
Countries
United States
Outcome results
None listed