Efficiency of a Nursing Intervention in Sleep Hygiene

NCT03857802 | Completed DMC

• 1 other identifier: JordiGol
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The relationship between the appearance of insulin resistance phenomena and insufficient or poor-quality sleep is scientifically documented. Objectives: To determine the effectiveness of an intervention based on behavioural techniques on sleep in the nursing consultation in the Primary Care setting to improve the level of HbA1c in patients diagnosed with diabetes mellitus 2 (DM2) or prediabetes. Hypothesis: Patients diagnosed with DM2 or prediabetes with poor sleep quality would improve their HbA1c levels after an intervention on healthier sleep hygiene practices. Sleeping 6 or less hours in adults diagnosed with DM2 or prediabetes would be related to worse metabolic control results. Patients diagnosed with DM2 or prediabetes who would value their sleep as poor quality would have poorer metabolic control. Methodology: Design: Not masked randomized clinical trial. Target population: Patients diagnosed up to the time of DM2 (E11) or prediabetes (R73, R73.9) with age over 18 attending the chronic nurses' follow-up visits of the Basic Health Area of Balaguer in the time range from November 2017 to December 2018. Determinations: Dependent variables: Glycemia and HbA1c. Independent variables: Sex, age, value of the Pittsburgh Sleep Quality Index (PSQI), declared hours of sleep, sleep efficiency, body mass index (BMI), pharmacologic antidiabetic treatment, changes in it, changes in diet, physical exercise and sleep hygiene. Statistical analysis: Analysis of the comparability of the groups and calculation of the confidence interval of the difference in the glycaemic values and HbA1c at the end of the follow-up, with respect to the initiation within the intervention group and within the control, and control group with respect to the group intervention.

Conditions

Sleep Disorder; Metabolic Glucose Disorders

Keywords

diabetes mellitus type 2; prediabetic state; sleep hygiene; haemoglobin A glycosylated; clinical nursing research

Outcome Measures

Primary Outcomes (1)

• Change of glycated hemoglobin levels.

  Change the level of HbA1c in patients diagnosed with DM2 or prediabetes by an intervention in sleep hygiene. The levels will be measured by blood test according to laboratory protocol.

  Three months

Secondary Outcomes (1)

• Change in sleep quality: Pittsburgh Sleep Quality Index

  Three months.

Study Arms (2)

Sleep hygiene intervention

EXPERIMENTAL

In the experimental group will proceed to the explanation of sleep hygiene measures to improve the quality of sleep. After 3 months, at the next health check, the quality of sleep questionnaire will be carried out together with the blood extraction.

Behavioral: Sleep hygiene intervention

No sleep hygiene intervention

NO INTERVENTION

In the no intervention group, the same follow-up visits and the same blood extractions will be carried out, but no educational activity on sleep will be carried out.

Interventions

Sleep hygiene intervention BEHAVIORAL

An individual education will be carried out following a bidirectional feedback method. It is intended to develop skills to make conscious and autonomous decisions. The explanation will consist: 1. Information and reading with discussion of the educational sheet: The 9 tips for a healthy sleep will be read, point by point. The nurse will be open to discuss those that generate doubt. 2. Confrontation: even if the patient does not ask any questions about it, it will be necessary to ask if he has understood the advice. 3. Participated information: Questions will be asked to the patient such as: "Did you already know any of these tips?". A telephone call per month will be made as an educational reinforcement to the intervention.

Sleep hygiene intervention

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 18 years.
• Hb1Ac greater than or equal to 5.7% at the time of diagnosis.
• PSQI greater than 5 points (poor sleep quality).
• Acceptance of participation in the study.

You may not qualify if:

• People diagnosed with:
• Obstructive Sleep Apnea Syndrome.
• Narcolepsy
• Fibromyalgia
• Dementias
• Schizophrenia
• Psychosis
• Major depression
• People with shift working hours.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Centro Atención Primaria - Institut Català de la Salut

Balaguer, Lleida, 25600, Spain

Location

Related Publications (15)

• Chaput JP, Despres JP, Bouchard C, Tremblay A. Association of sleep duration with type 2 diabetes and impaired glucose tolerance. Diabetologia. 2007 Nov;50(11):2298-304. doi: 10.1007/s00125-007-0786-x. Epub 2007 Aug 24.

  PMID: 17717644 RESULT

• Morselli LL, Guyon A, Spiegel K. Sleep and metabolic function. Pflugers Arch. 2012 Jan;463(1):139-60. doi: 10.1007/s00424-011-1053-z. Epub 2011 Nov 19.

  PMID: 22101912 RESULT

• Ayas NT, White DP, Al-Delaimy WK, Manson JE, Stampfer MJ, Speizer FE, Patel S, Hu FB. A prospective study of self-reported sleep duration and incident diabetes in women. Diabetes Care. 2003 Feb;26(2):380-4. doi: 10.2337/diacare.26.2.380.

  PMID: 12547866 RESULT

• Tasali E, Leproult R, Ehrmann DA, Van Cauter E. Slow-wave sleep and the risk of type 2 diabetes in humans. Proc Natl Acad Sci U S A. 2008 Jan 22;105(3):1044-9. doi: 10.1073/pnas.0706446105. Epub 2008 Jan 2.

  PMID: 18172212 RESULT

• Yaggi HK, Araujo AB, McKinlay JB. Sleep duration as a risk factor for the development of type 2 diabetes. Diabetes Care. 2006 Mar;29(3):657-61. doi: 10.2337/diacare.29.03.06.dc05-0879.

  PMID: 16505522 RESULT

• Gottlieb DJ, Punjabi NM, Newman AB, Resnick HE, Redline S, Baldwin CM, Nieto FJ. Association of sleep time with diabetes mellitus and impaired glucose tolerance. Arch Intern Med. 2005 Apr 25;165(8):863-7. doi: 10.1001/archinte.165.8.863.

  PMID: 15851636 RESULT

• Gangwisch JE, Heymsfield SB, Boden-Albala B, Buijs RM, Kreier F, Pickering TG, Rundle AG, Zammit GK, Malaspina D. Sleep duration as a risk factor for diabetes incidence in a large U.S. sample. Sleep. 2007 Dec;30(12):1667-73. doi: 10.1093/sleep/30.12.1667.

  PMID: 18246976 RESULT

• Knutson KL, Ryden AM, Mander BA, Van Cauter E. Role of sleep duration and quality in the risk and severity of type 2 diabetes mellitus. Arch Intern Med. 2006 Sep 18;166(16):1768-74. doi: 10.1001/archinte.166.16.1768.

  PMID: 16983057 RESULT

• Mallon L, Broman JE, Hetta J. High incidence of diabetes in men with sleep complaints or short sleep duration: a 12-year follow-up study of a middle-aged population. Diabetes Care. 2005 Nov;28(11):2762-7. doi: 10.2337/diacare.28.11.2762.

  PMID: 16249553 RESULT

• Bjorkelund C, Bondyr-Carlsson D, Lapidus L, Lissner L, Mansson J, Skoog I, Bengtsson C. Sleep disturbances in midlife unrelated to 32-year diabetes incidence: the prospective population study of women in Gothenburg. Diabetes Care. 2005 Nov;28(11):2739-44. doi: 10.2337/diacare.28.11.2739.

  PMID: 16249549 RESULT

• Copinschi G, Leproult R, Spiegel K. The important role of sleep in metabolism. Front Horm Res. 2014;42:59-72. doi: 10.1159/000358858. Epub 2014 Apr 7.

  PMID: 24732925 RESULT

• Nedeltcheva AV, Scheer FA. Metabolic effects of sleep disruption, links to obesity and diabetes. Curr Opin Endocrinol Diabetes Obes. 2014 Aug;21(4):293-8. doi: 10.1097/MED.0000000000000082.

  PMID: 24937041 RESULT

• Stamatakis KA, Punjabi NM. Effects of sleep fragmentation on glucose metabolism in normal subjects. Chest. 2010 Jan;137(1):95-101. doi: 10.1378/chest.09-0791. Epub 2009 Jun 19.

  PMID: 19542260 RESULT

• Itani O, Jike M, Watanabe N, Kaneita Y. Short sleep duration and health outcomes: a systematic review, meta-analysis, and meta-regression. Sleep Med. 2017 Apr;32:246-256. doi: 10.1016/j.sleep.2016.08.006. Epub 2016 Aug 26.

  PMID: 27743803 RESULT

• Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.

  PMID: 28875581 RESULT

Related Links

• Ezkurra P. Guía de actualización en diabetes mellitus tipo 2. Fundación redGDPS. 2016.
• Instituto del Sueño. ¿Qué es el sueño?
• Cunha MC, Zanetti ML, Hass VJ. Calidad del sueño en diabéticos tipo 2. Rev. Latino-Am. Enfermagem. 2008;16 (5): 850-855.
• SES. Pautas de actuación y seguimiento del Insomnio. 2016.
• Imazu MF, Nascimento B, Oliveira G, Aparecida C, Silva S. Efectividad de las intervenciones individual y en grupo en personas con diabetes tipo 2. Revista Latino-Americana de Enfermagem; 2015. 23(2)
• Menor Rodríguez María, Aguilar Cordero María, Mur Villar Norma, Santana Mur Cinthya. Efectividad de las intervenciones educativas para la atención de la salud. Revisión sistemática. Medisur. 2017;15 (1):75-84.

MeSH Terms

Conditions

Sleep Wake Disorders; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Prediabetic State; Sleep Hygiene

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Health Behavior; Behavior

Study Officials

• Cristina García Serrano, Nurse

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

• Jesús Pujol Salud, Doctor

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

• Lídia Aran Solé, Nurse

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

• Joaquim Sol, MSc

  Institut Català de la Salut-IDIAP Jordi Gol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse of Primary Care

Model Details: Experimental study, non-masked clinical trial of evaluation of an educational intervention in the field of Primary Care Nursing: Basic Health Area (BHA) of Balaguer. Two groups will be established randomly: experimental group and control group. In the experimental group will proceed to the explanation of sleep hygiene measures to improve the quality of sleep. In the control group, the same follow-up visits and the same blood extractions will be carried out, but no educational activity on sleep will be carried out.

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: September 1, 2017
• Primary Completion: December 15, 2018
• Study Completion: January 10, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years
• Access Criteria: The IPD sharing would require presentation of a study protocol in order to prove the consutant investigators work in the same research area.

Locations

ES (1)