Melatonin Receptor Agonists

Leeds Sleep Evaluation Questionnaire

The Leeds Sleep Evaluation Questionnaire (LSEQ) is a validated, standardised instrument for the subjective measurement of sleep parameters, which was developed in 1978.^1,2 It comprises ten questions, which retrospectively assess changes in four domains of sleep and morning behaviour:

ease of getting to sleep (GTS) – mean of questions 1–3
quality of sleep (QOS) – mean of questions 4 and 5
ease of awakening from sleep (AFS) – mean of questions 6 and 7
integrity of early morning behaviour following wakefulness (BFW) –mean of questions 8–10.^1,3

All four variables are independent domains to be used separately and not as a total LSEQ score.

Each of the ten questions is answered using a horizontal 100 mm visual analogue scale (VAS), whereby patients are asked to make a vertical mark through the scale at the point they feel best represents their answer to the question. Marks at 0 mm and at 100 mm represent the extremes of possible responses and those at 50 mm represent no change. Questions are usually answered on three consecutive days, and the mean score is recorded. In a clinical study, a change of 10 mm on the 100 mm VAS scale represents a 20% change from the mean, and a clinically significant change in patients’ status and can be considered appropriate for the definition of a ‘responder’.⁴

The LSEQ has been validated in a number of studies,^1,5which provide evidence for the LSEQ as a reliable and valid instrument to assess sleep aspects and daytime consequences under drugfree, as well as drug treatment conditions.⁶ The use of LSEQ has recently been validated in patients aged ≥55 years.^5,7 Furthermore, the mean scores from the LSEQ QOS questions form a valid clinical variable for assessing the quality of sleep – the primary outcome variable in many clinical trials. This is particularly relevant, as impaired QOS (assessed by LSEQ), was demonstrated to be strongly associated with impaired QOL.⁸ The LSEQ is currently the main outcome measure of sleep and daytime effects in clinical trials specifically studying sleep disorders.

Download the Leeds Sleep Evaluation Questionnaire⁹

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References:
1. Parrot AC, Hindmarch I. Factor analysis of a sleep evaluation questionnaire. Psychological Med 1978; 8: 325–329.
2. Zisapel N, Laudon M. Subjective assessment of the effects of CNS-active drugs on sleep by the Leeds sleep evaluation questionnaire: a review. Human Psychopharmacol 2003; 18: 1–20.
3. Wade AG, Ford I, Crawford G, et al. Efficacy of prolonged release melatonin in insomnia patients aged 55–80 years: quality of sleep and next-day alertness outcomes. Curr Med Res Opin 2007; 23 (10): 2597– 2605.
4. Zisapel N, Nir T. Determination of the minimal clinically significant difference on a patient visual analog sleep quality scale. J Sleep Res 2003; 12: 291–298.
5. Tarrasch R, Laudon M, Zisapel N. Cross-cultural validation of the Leeds Sleep Evaluation Questionnaire (LSEQ) in insomnia patients. Human Psychopharmacol Clin Exp 2003; 18: 603–610.
6. Zisapel N, Laudon M. Subjective assessment of the effects of CNS-active drugs on sleep by the Leeds sleep evaluation questionnaire: a review. Human Psychopharmacol 2003; 18: 1–20.
7. NEURIM, Data on file.
8. Rombaut N, Maillard F, Kelly F, et al. The quality of life insomniacs questionnaire (QOLI). Med Sci Res 1990; 18: 845–847.
9. Parrott AC, Hindmarch I. Factor analysis of a sleep evaluation questionnaire. Psychol Med. 1978 May;8(2):325-9