Improving Sleep Quality in ICU Patients

NCT02292134 | Completed Phase 3

• 1 other identifier: P081115
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors involved in poor sleep quality are environmental factors, such as light and noise, which are an unavoidable consequence of cares. The aim of the study is to evaluate the benefit of earplug and sleep mask on sleep architecture and quality in ICU patients.

Conditions

Intensive Care Unit Patients

Keywords

Sleep quality; Sleep architecture; Intensive care unit; Light; Noise; Earplug; Sleep mask

Outcome Measures

Primary Outcomes (1)

• Duration of sleep stage 3 and 4 (polysomnography)

  Significant change of the duration of sleep stage 3 and 4 (polysomnography) in the "protective strategy group" (earplug and sleep mask) as compared to the control group (conventional strategy).

  day 2

Secondary Outcomes (8)

• Nocturnal awakenings (polysomnography)

  Day 2

• Proportion of REM sleep (polysomnography)

  Day 2

• Total sleep time (polysomnography)

  Day 2

• Sleep time efficiency (polysomnography)

  Day 2

• level of anxiety and depression (HAD scale)

  At ICU discharge, an expected average of 3 weeks

Study Arms (2)

earplug and sleep mask

EXPERIMENTAL

Device: earplug and sleep mask

control

NO INTERVENTION

Interventions

earplug and sleep mask DEVICE

Individual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs

earplug and sleep mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission in the ICU with expected duration of stay \> 48hrs.
• Level of sedation \< 4 on Ramsay scale.
• Interruption of sedation \> 12 hrs
• Analgesia with a maximal dose of morphine \< 0.01 mg/Kg/h
• Vasopressive therapy not exceeding 0.3 mg/Kg/min for epinephrine and 10 mg/Kg/min for dopamine.
• Informed consent by patients or next of kind.

You may not qualify if:

• Known sleep disorder (apnea syndrome, narcolepsy, restless leg syndrome).
• Central nervous disease that might impact sleep architecture or the interpretation of EEG recordings.
• Severe liver encephalopathy (stage 3 or 4)
• Ongoing sepsis
• Pregnancy.
• Age \< 18 yrs.
• No health insurance.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6

Paris, 75013, France

Location

Related Publications (1)

• Demoule A, Carreira S, Lavault S, Pallanca O, Morawiec E, Mayaux J, Arnulf I, Similowski T. Impact of earplugs and eye mask on sleep in critically ill patients: a prospective randomized study. Crit Care. 2017 Nov 21;21(1):284. doi: 10.1186/s13054-017-1865-0.

  PMID: 29157258 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 17, 2014
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 17, 2014

Record last verified: 2013-11

Locations

FR (1)